5020, Sec 38 (W) Chandigarh |
Transcript of 5020, Sec 38 (W) Chandigarh |
INDIVIRTUS HEALTHCARE SERVICES (P) LTD. 5020, Sec 38 (W) Chandigarh | www.indivirtus.com
(An ISO 9001:2015 Certified Company)
Perfect Blend of Quality and Economy
INDEX (Click on the Area of your Interest)
Perfect Blend of Quality and Economy
Company Profile Management Team Executive Team Consortium Business Verticals Benefits of Outsourcing to Indivirtus Awards & Recognitions Global Footprints
Medical Writing Pharmacovigilance
PSUR / PBER Health Hazard Evaluation (HHE) Calculation of ADE / PDE / OEL HACCP
INDEX (Click on the Area of your Interest)
Perfect Blend of Quality and Economy
Clinical Trials Pre-Clinical Studies Bio-Equivalence Studies
GxP Services Audit Services Content Writing Qualification & Validation Training Computer System Validation
Formulation Development Analytical Services Contact Us
COMPANY PROFILE
Indian Company with Virtuousness
Indivirtus is a CRO which offers real time cost effective
solutions to healthcare industry. We help the healthcare
professionals and industry to maximize their efficiencies in
its core competencies while helping them grow their
business.
Perfect Blend of Quality and Economy
MISSION AND VISION
To be among the top ten globally competent medical and health economics company capable of providing timely and accurate solutions with highest integrity, while also providing a challenging and growth-oriented environment to our team of experts having a great sense of pride and achievement. VI
SIO
N
MIS
SIO
N To facilitate our customers with quality outcomes and financial prudence by creating and nurturing a team of highly competent and innovative professionals and employing state of the art technology, ensuring precise finesse and excellence.
QU
ALI
TY
Committed to ensure world class quality and excellent customer service. We endeavour to achieve this niche position through continuous up gradation and customer satisfaction while operating under an effective quality management system that fulfils needs of our customers with cutting edge technology.
Perfect Blend of Quality and Economy BACK
MANAGEMENT TEAM
Dr. Upendra Jain, M. Pharm, PhD (Chief Executive Officer) 15 years in Pharmaceutical Sales and Marketing, 12 years in Education
Ms. Veena Kanwar, MBA (HR & IT) (Managing Director) 15 Yrs in HR and Admin
Perfect Blend of Quality and Economy BACK
EXECUTIVE TEAM
Dr. Rajinder Kumar Jalali
Chief Scientific and Technical Advisor
30+ Years of experience in Pharma Industry and Patients Care
Ex-Global Head Pharmacovigilance And
Head Medical Affairs & Clinical Research Sun Pharmaceutical Ltd.
Mr. Hari Vayas Bansal
Director-GxP & Regulatory Services
25+ Years of experience in Pharma Industry Quality Management with Ranbaxy, Alkem, Panacea Biotec,
Mylan, Zydus Cadila, PT Sanbe Farma (Indonesia) & Unichem
Ex-Head Quality, Sun Pharma
Dr. Ashish Jain
Director-Business Development, Accounts &
Finance 17+ Years of experience in Chartered Accountancy, Marketing and Business
Development
Perfect Blend of Quality and Economy
Dr. Rajinder Kumar Jalali Chief Scientific and Technical Advisor
A Clinician and Pharma industry professional with more than 20 years of experience in heading, managing and advising functions of Pharmacovigilance at a global level (including USA, Canada, European Countries, LATAM, Australia, African Countries, Asia Pacific, India), Clinical Research and Development, Medical Writing and Medical Affairs.
PROFESSIONAL EXPERIENCE: Developing and maintaining an efficient global pharmacovigilance system by providing strategic
directions and leadership in pharmacovigilance operations, at global level to cross-cultural teams across different geographies, including North America & European countries.
Managing and leading teams involved in, End-to-End Clinical Trial Operations from site selection to site close outs for Phase I to IV trials, monitoring plans, Clinical Trial Protocols and Reports in compliance with ICH-GCP guidelines.
Leading teams in development of medical rationales, clinical / non-clinical expert reports for EU, Australia / other regulatory agencies and advising on 505(b)2.
Perfect Blend of Quality and Economy
Dr. Rajinder Kumar Jalali Chief Scientific and Technical Advisor
POSITIONS HELD: Global Head – Pharmacovigilance and Head Medical Affairs &Clinical Research, Sun
Pharma. Chairman – Saanvi Ethical Research LLP-IEC for conducting clinical trials in India. Governing Council Member – Sun Pharma Science Foundation and Sun Pharma
Community Health Care Society. Member – Quality Panel & Trainings, Pharmacovigilance Commission of India. Adjunct Professor – Centre for Translational & Clinical Research, Jamia Hamdard
University, Delhi Author - Book Chapters in "Pharmaceutical Medicine and Translational Clinical
Research, An Elsevier Publication 2018," covering topics in Pharmacovigilance; Clinical and Post Approval Safety Data Management, ICSR’s, DSUR & PSURs & RMP's.
Perfect Blend of Quality and Economy
Mr. Hari Vayas Bansal Director-GxP & Regulatory Services
PROFESSIONAL EXPERIENCE: Mr. Bansal is a Quality & compliance management professional with 25 years of
demonstrated accomplishments in building commercial quality organizations and implementing compliance and quality improvements, with wide experience in Quality Assurance, Quality Control, Microbiology, Training and Development, Vendor Qualification and Manufacturing.
Mr. Bansal has served in Sterile and Non-Sterile Finished formulations, Dry Powder Injections/Ophthalmic/Oral Solid Dosages manufacturing facilities at Senior Managerial positions, responsible for Quality and Compliance in organizations of repute i.e. Sun Pharma, Mylan, Zydus Cadila, Panacea Biotec, Unichem, Alkem, Ranbaxy and PT Sanbe Farma (Indonesia)
He has been instrumental in the implementation of GMP/Quality systems in compliance with guidelines/regulations like Schedule M, ICH Q7, USFDA, MHRA, MCA, TGA, ANVISA, MCC, WHO, 21 CFR Part 210 & 211 etc.
Perfect Blend of Quality and Economy
Mr. Hari Vayas Bansal Director-GxP & Regulatory Services
AREAS OF EXPERTISE: Investigation, Risk Assessment and Root Cause Analysis Audit & Compliance Reduction of QMS elements related to Human errors by monitoring Quality Metrics as per
FDA,MHRA guidelines Vendor Qualification FDA remediation activities Third Party Audits, Due Diligence Audits Productivity improvement by streamlining processes through end to end mapping, gap
assessment, trainings and resource availability. Qualification and Validation of Equipment, System, Facility & Utility Computer System Validation & Computer System Assessment Developmental Trainings & Professional Trainings
Perfect Blend of Quality and Economy BACK
INDIVIRTUS CONSORTIUM One Stop solution for all Pharmaceutical Needs
Indivirtus consortium is a group of companies, being lead by Indivirtus Healthcare
Services. Idea is to provide one stop solutions to almost all the services required
by any Pharmaceutical Company.
All the consortium partners are carefully chosen to meet the basic mantra of “A
Perfect Blend of Quality and Economy”. The group companies have
accreditations and certifications to meet the regulatory requirements. Therefore,
you can outsource all your requirements to Indivirtus Healthcare and enjoy the
hassle free services.
Perfect Blend of Quality and Economy BACK
BUSINESS VERTICALS
Environmental / Toxicological Services (PDE/ADE/OEL Calculations, Genotox evaluation)
Clinical Trials Pharmacovigilance / Drug Safety Health Hazard Evaluation e-CTD/CTD submissions GxP Services (GMP, GLP, CSV, CSA, GDP, ……) HACCP Formulation Development Pre-Clinical Studies Analytical Method Development and Validation Bioequivalence studies
Perfect Blend of Quality and Economy BACK
BENEFITS OF OUTSOURCING TO INDIVIRTUS HEALTHCARE
Perfect blend of quality and economy Experienced team of certified toxicologist Experienced teams of authors 100% compliant to regulatory authorities Data security Quick and time bound delivery Support during audits, if required Information on any updates in data/values Preferred choice of sponsors
Perfect Blend of Quality and Economy BACK
RECOGNITIONS Recognized
as “A Cost
Effective Healthcare
Service Provider”
by Prime
Insights Rated as “Top 10 Clinical Trials
Service Provider”
by Swift & Lift
Perfect Blend of Quality and Economy
RECOGNITIONS
Perfect Blend of Quality and Economy
Recognized as “Company of the Year 2020”
By - CEO Insights Certified as ISO 9001:2015
BACK
GLOBAL FOOTPRINTS
INDIA
UAE
UNITED STATES
FRANCE
BANGLADESH
UNITED KINGDOM
SRI LANKA
Perfect Blend of Quality and Economy BACK
Regulatory Writing
Nonclinical Services
Clinical Services
NON-CLINICAL SERVICES Non-clinical modules of Common Technical Document
(CTD): Non-clinical study reports (Module 4), Non-clinical summaries (Module 2.6) and Non-clinical overviews (Module 2.4).
Determination of Health Based Exposure Limits: Permitted Daily Exposure (PDE), Occupational Exposure Limit (OEL) and Occupational Exposure Band (OEB).
Genotox Evaluation using Derek Nexus and Sarah Nexus OR ToxTree
Toxicological Assessment Reports: Toxicology Profile for Cosmetic ingredients, Cosmetic Product Safety Report (CPSR).
MEDICAL WRITING
Perfect Blend of Quality and Economy
Regulatory Writing
Nonclinical Services
Clinical Services
CLINICAL SERVICES Clinical trial documents: Investigator’s Brochure,
Protocol, Informed Consent Form, Case Report Forms, Statistical Analysis Plan, Clinical Study Report etc.
Clinical modules of Common Technical Document (CTD)/Dossier: clinical study reports (Module 5), clinical summaries (Module 2.7) and clinical overviews (Module 2.5).
Clinical Evaluation Reports for Medical Devices
Others: Drug Labelling, Biowaivers, Clinical trial waivers and GAP analysis of dossiers – clinical sections.
MEDICAL WRITING
Perfect Blend of Quality and Economy BACK
Most Advanced Database Cloud Based E2b(R2)/(R3) Compliant Automated Literature Module Automated Signal Detection
PHARMACOVIGILANCE
ADR REPORTING SERVICES Individual Case Safety Reports (ICSRs), Literature Review Periodic Reports: Periodic Adverse Drug Experience Report (PADER) Periodic Benefit Risk Evaluation Report (PBRER) Periodic Safety Update Report (PSUR)
Developmental Safety Update Report (DSUR) Annual Safety Reports (ASRs)
SPECIALIZED SERVICES Medical Information Centre Risk management plan
Perfect Blend of Quality and Economy
Using Artificial
Intelligence
Risk-Benefit analysis Signal Management
PHARMACOVIGILANCE PROCESS OVERVIEW
ICSR Processing
Receipt and Collection of Individual Safety information (Intake on Day 0)
Individual Safety Information Transmission and ICSR Registration (Book-in)
Data Entry & Case Assessment (DECA) - All the events must be coded using Medical Dictionary for Regulatory Activities (MedDRA)
Medical Review (MR)
Quality Control (QC)
Case distribution to Business Partner (Finalization)
Distribution and Submission to Regulatory Authority
Perfect Blend of Quality and Economy
PHARMACOVIGILANCE PROCESS OVERVIEW Need for Scientific & Medical Literature in PV
Perfect Blend of Quality and Economy
Scientific & Medical Literature is a ‘Significant’ – Source of Information for monitoring of Medicinal Product in relation to: Safety profile & Risk-Benefit Balance
By detecting New “Safety Signals” OR “Emerging Safety Issues”
……as per GVP Module VI “Management & Reporting of Adverse Events to Medicinal Products”
Perfect Blend of Quality and Economy
US FDA EMA
Frequency Not Identified but mostly weekly at least. Weekly
Author’s Attribution Applies as Implicit Or Explicit Applies as Implicit Or Explicit
Reporting Serious / Unexpected only Serious & Non-Serious
Exclusions No such exclusions; All Active Moiety
Exclusions Applies as per GVP Module VI
PHARMACOVIGILANCE PROCESS OVERVIEW Requirements of Literature Screening for US FDA & EMA
BACK
PSUR / PBRER Periodic Safety Update Report (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRER)
These are pharmacovigilance documents intended to provide an evaluation of the Risk-Benefit balance of a medicinal product for submission by marketing authorization holders at defined time points during the post-authorization phase. Goal: To summarises any new efficacy and effectiveness information To Summarises relevant new information that may impact the benefit risk profile of the MAH
product Examine whether new safety information is in accord with previous knowledge of the
benefit risk profile
ICH E2C(R1) “PSUR” is replaced by ICH E2C(R2) “PBRER” When a new Product is authorized for marketing, that decision is based on a Benefit-Risk balance. If the benefits are greater than risks, then it is known as Positive Benefit-Risk balance
Perfect Blend of Quality and Economy
PSUR's are assessed by Regulatory Authorities and the outcomes can be: Maintenance of MAH (Marketing Authorization Holder)
Potentially Withdrawal or Suspension or Restriction on distribution of MAH’s product Variation in Reference Safety Information (If there is an update in the package leaflet)
IBD (International Birth Date): The date of the first marketing authorisation for a medicinal product granted to the MAH in any
country in the world.
EURD (European Union Reference Dates) list EURD list refers to an excel sheet shared by EMA website explaining the frequency of PBRER's
required for submission of different products. If Benefit-Risk balance of a medicinal product changes, then there is a need for Re-assessment.
Minimizing Risks and optimizing Benefits throughout the life-cycle of an medicinal product will promote and protect Public health and enhance patient safety by avoiding un-necessary risks to patients.
ASSESSMENT OF PSUR/PBRER
Perfect Blend of Quality and Economy BACK
Indivirtus offers best quality data services in product recall(s) through delivery of: Health Hazard Evaluation (HHEs) for classifying a voluntary recall by a firm Health Risk Assessments (HRAs) for possible harm from a defective or malfunctioning device
HHE Reports: HHE reports allow the regulatory agency’s physician or committee to characterize the total health risk
of the device/product.
What Indivirtus do: Ensure to deliver best quality reports keeping standards quality bar high with respect to the regulatory
needs (FDA etc.) reflecting the compliant language as per the recall regulations with customer compliance.
Try that our customers receive favourable responses from authorities and recalls are avoided. Help the clients to take best measures to resolve safety issues in the device as per
recommendations of authorities.
HEALTH HAZARD EVALUATION (HHE)
Perfect Blend of Quality and Economy BACK
CALCULATION OF HEALTH BASED EXPOSURE LIMITS PERMITTED/Acceptable DAILY EXPOSURE (PDE)/(ADE) & Occupational Exposure Limit (OEL)
EMA guideline (EMA/CHMP/CVMP/SWP/169430/2012) Current: Cleaning is a risk-reducing measure and carry-over limits for cleaning validation studies are widely used in the pharmaceutical industry. A variety of approaches are taken in order to establish these limits and often do not take account of the available pharmacological and toxicological data.
New Approach: Review and evaluation of pharmacological and toxicological data of individual active pharmaceutical ingredients (API) enables determination of science-based threshold levels.
PDE/ADE: Permitted/Acceptable Daily Exposure “A dose that is unlikely to cause an adverse effect if an individual is exposed, by any route, at or below this dose every day over a lifetime”
Perfect Blend of Quality and Economy
PDE/ADE CALCULATION
Shared facility guideline Medical products provide a benefits to the intended patient or target animal, however as a cross contaminant, they provide no benefit to the patient or target animal and may even pose a risk.
Cross contamination DRUG PRODUCT
Product A Cross contamination DRUG PRODUCT
Product B
PDE
RISK
-Patient Population -Target Animal
To be implemented for all medicinal
products in shared manufacturing
facilities
Perfect Blend of Quality and Economy
PDE/ADE CALCULATION Information Necessary
Non-Clinical Safety pharmacology, Single dose toxicity, Repeated dose toxicity, Genotoxicity, Carcinogenicity, Reprotoxicity, Sensitization
Clinical Pharmacological effects Dosing regime
Adverse Events - severity / incidence
Perfect Blend of Quality and Economy
PDE/ADE CALCULATION Factor Values as per ICH Q3DR1
F1 = A factor to account for extrapolation between species Factor 1 – 12, based on body surface conversion Not all species assessed
F2 = A factor of 10 to account for variability between individuals
F3 = A variable factor to account for toxicity studies of short-term exposure Factor 1, 2, 5, 10 Life-long (rodent/non-rodent) versus study duration: acute, chronic, organogenesis (reprotoxicity)
F4 = A factor that may be applied in cases of severe toxicity Factor 1, 5, 10 Potential subjective assessment of ‘severe’ in studies other than those described in the guideline (i.e.
reprotoxicity) F5 = A variable factor that may be applied if the no-observed-effect- level ‘NOEL’ was not established
Factor 1-10 E.g. NOEL(1)/NOAEL(1-5), LOEL(5-10)/LOAEL(10)
Perfect Blend of Quality and Economy
Perfect Blend of Quality and Economy
PDE/ADE CALCULATION
EXPERIENCE IN PDE/ADE CALCULATION
Experienced team of toxicologist have been the key to train the bunch of enthusiastic quick learners to produce more than 2800 PDE/OEL in a short period of 2.5 years.
More than 130 sponsors across the globe have shown the confidence in team INDIVIRTUS simply because we offer a Perfect Blend of Quality and Economy.
Many of these sponsors have under gone inspections by various regulating bodies but none of them raised any questions on reports produced by team INDIVIRTUS.
Perfect Blend of Quality and Economy BACK
HACCP is an internationally recognized risk-based method of identifying and managing food safety related risk in food/drug supply chain facilities. HACCP presents analysis and controls of Biological, Chemical, Physical, Allergenic and Nutritional Hazards right from Raw Material Procurement to Consumption of the Finished Product.
Therefore, Indivirtus will help you build a structure that withstands uniform requirements of the Codex Alimentarius Commission (CAC) – Established by the World Health Organization.
Indivirtus help you to: Identification of the Critical Points where Product/Drug Safety can be compromised Analysis and Mapping of the CCPs, OPRPs and PRPs across the entire Supply
Chain Providing Control Measures or Check Points to Contain Contamination Hands on Training on implementation of the entire system
HAZARD ANALYSIS CRITICAL CONTROL POINTS (HACCP)
Perfect Blend of Quality and Economy BACK
CLIENTS WHO ENCOUNTERED AUDITs
Dr. Reddy’s Lab
Hetero Drugs
Ajanta Pharma
Ahlcon Parentrals (B Brown Group of companies)
Unicure Remedies
Bioplus Labs
Intas Pharmaceuticals
Sentiss Pharma
Perfect Blend of Quality and Economy
CLINICAL TRIAL Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions and side effects.
Phase Primary goal Typical number of participants Notes
Phase I Testing of drug on healthy volunteers for safety; involves testing multiple doses
20–100 normal healthy volunteers To check for efficacy and safety
Phase II Testing of drug on patients to assess efficacy and side effects
100–300 patients with specific diseases
determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever
Phase III Testing of drug on patients to assess efficacy, effectiveness and safety
300–3,000 patients with specific diseases
determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect
Phase IV Post marketing surveillance – watching drug use in public
anyone seeking treatment from their physician watch drug's long-term effects
Perfect Blend of Quality and Economy BACK
PRE-CLINICAL STUDIES
Perfect Blend of Quality and Economy
Incorporated in 2010 by experienced team of scientific professionals, our pre-clinical CRO partner offers an integrated platform to support a diversified customer base.
Growing Company
Fastest Growing Indian Company Excellence Award 2017 by International Achievers Conference
Diversified Customer Base
Mix of Pharmaceutical, Biotech, Medical Device, Pesticide, Herbal and Vaccine producing customers from across the globe.
Integrated Services
Offers a range of Preclinical Toxicology, Pharmacokinetics, Biology, Pathology, Biocompatibility Testing and Regulatory submission, Standard for Exchange of Nonclinical Data (SEND) services.
Best-in-Class Talent
Experienced scientific and management team having worked with global pharmaceutical, biotech and other companies.
Delivery Infrastructure
CPCSEA Approved Facility (1723/PO/RcBiBt/13/CPCSEA) GLP Certified (GLP/C-127/2018). Applied for Local FDA and DSIR certification
Awards
‘Preclinical Research Excellence Award’ in First Global Pharma Summit 2K19’ organized by DocRoSh Global Solutions, 2019 Indian Leadership Award for Industrial Development’ from All India Achievers
Foundation in 2017 to Our CEO and Director
• December - Company incorporated with modest and personal investment . 2010
• Establishment of Animal Research facility and support functions.
2013 • Inspection and approval of Animal Facility by the CPCSEA
2014 • Application for GLP certificate. First foreign client 2015
• Standardization of Toxicity studies and Providing services
2016 • Expansion for breeding, bought own Land
2017 • GLP Pre-inspection, Solar plant
• Received GLP Certificate
2018
2012
2018
• Expand to in-vitro lab Capitalizing on our Strengths, we are
growing with Support and Faith of
clients
Presence in UK, inhalation Facility 2019
Perfect Blend of Quality and Economy
PRE-CLINICAL STUDIES Key Milestone Achievements
Acute toxicity Studies (including 6 Pack) Single-Dose Toxicity Study in Rodents Acute Eye Irritation study Acute Dermal Toxicity Acute Skin sensitization study Guinea Pig Maximization study Acute Systemic toxicity study Acute Inhalation toxicity study
Repeated Dose toxicity Studies 7-14-Day Repeat Dose Toxicity Study 28-Day Repeat Dose Toxicity Study 90-Day Repeat Dose Toxicity Study 180-Day Chronic Toxicity Study Repeat Dose Inhalation Studies
Genetic Toxicity Studies Reverse Mutation Assay (Ames Assay) Micronucleus Test (MNT) Chromosomal Aberration Assay
Developmental & Reproductive Toxicology Embryo Foetal Development Study in Rodents and
Rabbits - Dose Range Finding and Definitive studies
Male and Female Fertility Study
Species: Rat, Mice, Rabbit, Guinea Pig, Hamster Species: Pig, Dog (3rd Party Collaboration)
Routes Oral, Intravenous (IV), Intramuscular (IM), Intraperitoneal (IP), Subcutaneous, Intra-nasal, Intra-cameral, Sub-conjunctival, Intra-dermal, Intra-stromal, Ocular, Rectal, Penile, Vaginal, Topical, Cheek pouch
Perfect Blend of Quality and Economy
PRE-CLINICAL STUDIES Toxicology Services
In Vitro Cytotoxicity Test (ISO 10993:5) Extract Elution test
Hemocompatibility Studies (ISO 10993:4) In vivo thrombosis In vitro hemolysis (ASTM F756-17) Coagulation and Platelet Complement activation
Skin Sensitization (ISO 10993:10) GPMT Buehler Test
Irritation Studies (ISO 10993:10) Mucosal Irritation (ocular, penile, vaginal, rectal, oral) Skin Irritation / intracutaneous reactivity test
Systemic Toxicity (ISO 10993:11) Acute systemic toxicity Repeated dose (14, 28, 90 day) toxicity studies
Implantation Studies (ISO 10993:6) Sub-cutaneous implantation Intra-muscular implantation Bone implantation
Special Customized studies Sub-acute (28 day) or Sub-chronic (90 day) cum
implantation studies (clinical, gross and histopathology)
Genotoxicity Test (ISO 10993:3, OECD) Gene mutations in bacteria (GL 471) Gene mutations in mammalian cells (GL 476) Clastogenicity in mammalian cells (GL 473) Mouse Micronucleus test in rodents (GL 474 Metaphase analysis in rodent bone marrow (GL
475) Unscheduled DNA synthesis test with
mammalian liver cells (GL 486)
Perfect Blend of Quality and Economy
PRE-CLINICAL STUDIES Medical Device Biocompatibility Studies, Leachable/Extractable and Material Testing
Species Rat, Mice, Rabbit, Guinea Pig
Pig, Dog (3rd Party Collaboration)
Routes Oral, intravenous (bolus and infusion), intra-
peritoneal, subcutaneous, intranasal, intramuscular, intra-rectal or intra-ocular
Biological Matrices Blood/plasma/urine/feces; Bile, Cerebrospinal fluid, Various tissues such as brain, lung, heart,
liver, kidney, spleen, skeletal muscle, Ocular tissues like aqueous humor, vitreous
humor, lens, cornea, optic nerve
Single, multiple and cassette dosing of compound(s)
Dose escalation study (dose linearity and range finding)
Tissue distribution study (brain, heart, liver, lung, kidney, Eye etc.)
Rank-ordering compounds/formulations Determination of fundamental PK
parameters (Tmax, Cmax, AUC, clearance, oral bioavailability, volume of distribution, etc.)
Blood brain barrier PK-PD Evaluation
Perfect Blend of Quality and Economy
PRE-CLINICAL STUDIES Pharmacokinetic Services
PRE-CLINICAL STUDIES Biology Services
Inflammation and Pain Models Arthritis induction using collagen Colitis induction using DSS or acetic acid Psoriasis-like skin disease Excision wound healing model Osteoarthritis induction Carrageenan induced paw oedema Mechanical, thermal, cold Hyperalgesia - CFA Neuropathic pain using Paclitaxel L-5 & L-6 spinal nerve ligation (SNL) Partial Sciatic Nerve ligation (pSNL)
Antipsychotic Activity Models Novel object recognition test Psychosis and social interaction deficit Disruption of Conditioned Avoidance Response Restoration of pre-pulse inhibition (PPI) Neurobehavioral assays
Metabolic Disorders Models STZ induced Diabetes, Diabetic neuropathy Hypothyroidism in rodents Acute and Chronic kidney diseases
Safety Pharmacology Models Rota rod test and Grip strength test Tail flick test, Hot plate test Noninvasive (tail cuff) BP recording
Osteoporosis Models Ovariectomy induced osteoporosis Thyroxine or Ethanol induced osteoporosis Hypercalcemia using Retinoic acid
Biological Reactivity Test (USP 87 & 88) Acute systemic Toxicity test Intracutaneous reactivity test Implantation test
Pharmacopoeal Testing Pyrogen Test Abnormal toxicity test
Perfect Blend of Quality and Economy BACK
To assess expected in-vivo biological equivalence of two proprietary preparations of a drug. If two pharmaceutical products are said to be bioequivalent, then they would be expected to be the same for all intents and purposes. Location – Mumbai, financial capital of India. 15 minutes drive from airport Established in 2008, Total Area Spread: 10500 Sq ft. Sub-divided into Clinical, Bio-analytical, Statistical, Information Technology
and Quality Assurance department. Total Staff Strength – 60 [excluding contractual staff] Proficiency: Bioequivalence and Bioavailability studies Registered with CDSCO
Perfect Blend of Quality and Economy
BIO-EQUIVALANCE STUDY
42-bed ward with 2-bed ICU
Up-to-date critical care instrumentation and medical inventory, MAC 2000 ECG machines with online data capture of 12-lead ECG.
Self-owned ambulance
Tie-up with Super-specialty hospital [7-10 minutes drive]
Triple access-controlled drug store with humidity chamber, LAF and refrigerator
Dining room, pantry and change room separated from ward
Phlebotomy and sample separation room adjacent to ward thereby restricting movements
Dedicated counseling area for ICF presentation with audiovisual recording.
In-house blank plasma collection for research purpose.
Perfect Blend of Quality and Economy
BIO-EQUIVALANCE STUDY Facilities
LC-MS/MS – can detect up to sub-pico gram [LLOQ]
Sample organizer for high, uninterrupted throughput
SDMS software for online data capture and back-up
> 160 [and counting] bioanalytical method databank
Access-controlled sample storage room with 6 deep freezers [-70°C and -30°C]
Eurotherm Data logger for constant online temperature recording of freezers/ refrigerators
Sodium vapor lamps for light-sensitive drugs
Eurotherm data logger for continuous recording of temperature
Robust back-up system through UPS [60 KV] and Genset [250 KV]
Perfect Blend of Quality and Economy
BIO-EQUIVALANCE STUDY Instrumentation and Storage Facility
Experienced biostatisticians having faced regulatory audits of FDA, EMA & WHO
All the data processed using SAS software [SAS 9.4]
Conversant with SDTM and aDAM requirements of FDA
Conformation to ICH E-9 guidelines for clinical studies
Independent QA department reporting to management
Robust training program backed with assessment for GCP/ GLP compliance
Managing Data integrity – Paper and electronic data.
All activities ensure compliance to SOP, protocol
Reports generated are in accordance with ICH E-3 guidelines
eCTD compliant scanning of entire BE dossier [Module 5] with FDA/ EMA specifications.
Perfect Blend of Quality and Economy
BIO-EQUIVALANCE STUDY
Central Drug Standard Control Organization [CDSCO] – India Medicines Control Council [MCC] – South Africa Medicines and Healthcare products Regulatory Agency – UK Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel
und Medizinprodukte, BfArM) – Germany United States Food and Drug Administration – US European Medical Agency – European Union (EU) Therapeutic Goods Administration – Australia World Health Organization – Geneva Pharmaceutical Inspection Cooperation Scheme (PIC/s)
Perfect Blend of Quality and Economy
BIO-EQUIVALANCE STUDY
Perfect Blend of Quality and Economy
BIO-EQUIVALANCE STUDY
BA/BE studies in male and female volunteers involving fasted, fed, multiple dose [steady-state] design
BA/BE studies in male and female volunteers of other route of administration than oral [Topical / Sublingual / ODT / Injectable]
Drug interaction studies Dose proportionality/ Dose linearity studies Proof-of-concept studies for generic drugs BA Studies on dermatological products Relative bioavailability studies Bioanalytical method development and validation technology End-to-end management of Phase II, III and IV clinical trials Protocol, ICF, CRF preparation for clinical trials/ BE studies Regulatory and bio-statistical assistance Module 2.4, 2.5, 2.6 and 2.7 SDTM and aDAM compliant data modules
BIO-EQUIVALANCE STUDY
Perfect Blend of Quality and Economy BACK
Good Manufacturing Practice (GMP)
Good Clinical Practice (GCP)
Good Documentation Practice (GDP)
Good Laboratory Practice (GLP)
Good Warehousing Practice (GWP)
Good Distribution Practice (GDP)
Good Automated Manufacturing Practices (GAMP)
GxP SERVICES
Perfect Blend of Quality and Economy BACK
We provides Auditing Services as per ICH-Q7, WHO-GMP, USFDA (21 CFR), MHRA, EU-GMP & PIC'S Regulatory Requirements.
GAP Assessment & Due Diligence Audits Vendor Assessment and Vendor Management Raw Material (KSMs, Intermediates and APIs) Vendor Audits and Supplier Audits Finished Formulations Vendor Audits, Supplier Audits and Market Authorization Audits Packing Materials Vendor Audits and Supplier Audits Internal Audits and Social Audits Third Party / Loan Licence / P2P Manufacturing Audits Pre- and Post- Regulatory Audit Investigation Audit (Deviation, Market Complaint, OOS, OOT, Etc.) Surveillance Audit Mock Audit
GxP SERVICES GMP Auditing Services
Perfect Blend of Quality and Economy BACK
Preparation of Site Master File (SMF)
Preparation of Validation Master Plan (VMP)
SOP’s Writing
QMS & Data Integrity Policy Writing
Preparation of Validation / Qualification Protocol & Reports
Development & Preparation of Training Material
Preparation Of Trends
Preparation of PowerPoint Presentation
Preparation of HR / Admin Polices
Many More....!!
GxP SERVICES cGMP Content Writing Services For Pharma / Healthcare / Biotech / Lifesciences Industry
Perfect Blend of Quality and Economy BACK
Preparation of Scientific & Effective Protocol as per Current Regulatory Requirements
Training on Protocol & Performance of Activity Planning of Validation / Qualification Activity Effective Execution of Validation / Qualification activity Effective & Scientific Report Writing, Trend Preparation and Summary Report, We provides above services for:
And All Validation / Qualification services for your Utility, Equipments, Instruments, Micro Lab. Area, Facility, Process etc.
GxP SERVICES Validation / Re-Validation / Qualification / Re-Qualification & Periodic Verification
Perfect Blend of Quality and Economy
Computerized Systems Validation Water System Qualification Air Compressor Qualification Process Validation Shipping / Transport Validation Media Fil
Computer System Assessment HVAC System Qualification Area Qualification Clean Room Qualification Cleaning Validation Temperature Mapping
BACK
GxP SERVICES On-Site / Off-Site cGMP Training
Professional Trainings Internal Auditor
Quality Management System
Effectiveness of Trainer
Quality Risk Assessment,
Computer System Validation
Supplier Management System
HVAC System
Water System
Good Documentation Practice
Developmental Trainings Effective Communication
Technical Report Writing
Train the Trainer
Conflict Management
Leadership Skills
Stress Management
Quality Culture
Perfect Blend of Quality and Economy BACK
Includes the Commissioning and Qualification of equipment/computer system validation of PLC / HMI / SCADA and preparation of protocols and reports
Includes Data Integrity Forensics and CSV for Laboratory System
The complete Process Includes: Validation Plan Initial Risk Assessment/GxP Assessment User Requirements Specifications and
Functional Specification Risk Assessment Installation Qualification (IQ) Operational/Performance Qualification (OPQ) Traceability Matrix Validation Summary Report
GxP SERVICES Computer System Validation
Perfect Blend of Quality and Economy BACK
FORMULATION DEVELOPMENT Research and Development Center
Located in Mumbai, India
Over 10,000 sq. ft. premises State of the Art Facility
Strong Technical Expertise Dedicated to Timelines
Perfect Blend of Quality and Economy
Clean Room Partition Dedicated AHUs (HVAC System) Epoxy Flooring
LAF and Pass-box For Dispensing
Ability to Handle Potent Drugs
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT Research and Development Center
Quality In Design Complex Injectable Formulations Solid Oral Formulation
Liquid / Semisolid Formulations
Product Life Cycle Management
Value Added Nutraceuticals
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT Our Developmental Capabilities
Modified Release Formulations
Delayed Release Formulations
Oral Disintegrating Formulation
Multi Unit Particulate Systems (MUPS) Nutraceutical Formulations Solubility / Bioavailability
Enhancement
Injectable Formulations
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT Our Technical Capabilities
Formulation Development In Process Quality Control Analytical Development
Dispensing Booth Tap Density Tester Micro Balances
High Shear Mixer (Multi Capacity) Moisture analyser Sonicator
Universal Blender (Multi Capacity) Particle Size Analyser Centrifuge
Multi Mill ( Dry and Wet Milling) Tablet Friability Tester Water System (Type 1 and 2)
Fluidized Bed Dryer and Processor Tablet Disintegration Tester Tablet Dissolution Tester (Auto Sampler)
D Tooling Compression Machine Tablet Hardness Tester UV Visible Spectrophotometer (21 CFR)
Tablet Auto Coater pH Meter HPLC with PDA Detector ( 21 CFR)
Autoclave Water System HPLC with UV Detector ( 21 CFR)
Magnetic Stirrer Hot Air Oven (25°C-300 °C) Karl Fisher Analyser ( 21 CFR)
High Speed homogenizer Stability Chambers with 40°C/75%RH; 30°C/75%RH; 25°C/60%RH; 2°C-8°C (with 24x7 Back up and 21 CFR complying Software)
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT Major Equipments, Machines & Set-up
More Than 15+ Patent Application Applied Globally including granted patents Stabilized prolonged release pharmaceutical composition comprising atypical
antipsychotic Multiple unit particulate system comprising Metoprolol Succinate Vilazodone tablets with improved dissolution Topical Aceclofenac formulation Extended release composition of Acetazolamide Pharmaceutical composition of Cannabinoid receptor antagonist Extended release pharmaceutical composition containing Metoprolol Succinate Modified release formulation of Rimonabant Taste masked composition containing Asenapine Maleate
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT Granted Patents Applications
More Than 15+ Patent Application Applied Globally including granted patents Solubility enhancement of Boswellia
Serrata using melt technology Curcumin formulation using hot melt
extrusion technology Pharmaceutical composition comprising
Dapagliflozin Curcuminoid compositions Platform technology for drying and taste
masking Platform technology
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT Granted Patents Applications
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT List of Products Developed- Updated List as on Oct 2020
Product RLD Used
For Product Development
Development Status
Pilot BE
Scale Up
Pivotal BE
Technology Transfer Remark
Open Market Available for Out Licensing
USA EU China Australia South East Asia
Other
Ranitidine Capsules (150 mg, 300 mg) Zentac Done BCS III
Waiver Done Done Done Done
Famotidine Tablets (10 mg, 20 mg) Gaster Done Done Done Done Done Filed with
NMPA
Nimodipine Tablets (30 mg) Nimotop Done Done Done Done Done Filed with
NMPA
Dexamethasone Acetate Tablets (0.5 mg, 0.75 mg) Dectanyl Done Done Done Done Done Filed with
NMPA
Isosorbite Mononitrate Sustained Release Tablets (60 mg) Imdur Done Oct
2020 Done Dec 2020
Nov 2020
Ready for BE
Atorvastatin Calcium Trihydarte Tablets (10, 20, 40 mg) Lipitor Done TBD TBD TBD TBD Ready for
TT
Hydroxychloroquine Sulphate Tablets (200 mg) Plaquenil Done NA Done Done Done ANDA
Approved
Sugammadex Injection 100 mg/ml (2m and 5 ml) Bradion Done NA Done NA Done
EB Stability Initiated
Ongoing
Exclusivity for mentioned Region
Stage Completed
Open for Out-Licensing
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT List of Products Developed- Updated List as on Oct 2020
Product RLD Used
For Product Development
Development Status
Pilot BE
Scale Up
Pivotal BE
Technology Transfer Remark
Open Market Available for Out Licensing
USA EU China Australia South East Asia
Other
Melatonin Prolonong Released Tablets (2 mg) Circardin Done NA Oct
2020 Nov 2020
Oct 2020
AMV Ongoing
Chlorpromazine Hydrochloride Tablets (10 mg, 25 mg, 50 mg, 100 mg, 200 mg)
USL Done Done Done Ongoing Done Pivotal
BE Ongoing
Pregabalin Capsules (25, 50, 75, 100, 150, 200, 225, & 300 mg)
Lyrica Done BCS I Waiver
Dec 2020
BCS I Waiver
Dec 2020
Ready for TT
Linezolid Tablets (600 mg) Zyvox Done NA Dec
2020 Nov 2020
Dec 2020
Ready for TT
Olmesartan + HCTZ Tablets (20/12.5, 40/12.5, 40/25 mg)
Benicar HCT
Ongoing Nov 2020
Nov 2020
Dec 2020
Feb 2021 Ongoing
Metformin ER Tablets (500 and 1000 mg) Glumetza Done Oct
2020 Nov 2020
Dec 2020
Feb 2021
Ready for TT
Mesalamine DR Tablets (1.2 gm) Lialda Done Oct 2020
Nov 2020
Dec 2020
Feb 2021
Ready for Scale Up
Ongoing
Exclusivity for mentioned Region
Stage Completed
Open for Out-Licensing
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT List of Products Developed- Updated List as on Oct 2020
Product RLD Used
For Product Development
Development Status
Pilot BE
Scale Up
Pivotal BE
Technology Transfer Remark
Open Market Available for Out Licensing
USA EU China Australia South East Asia
Other
Mesalamine Extended Release Pellets (90 and 96%)
Pentasa Sachets
Done NA Oct 2020 NA Jan
2021 Ready for
TT
Mesalamine Extended Release Capsules (250 and 500 mg)
Pentasa Capsules
Ongoing Nov 2020
Jan 2021
Feb 2021
Apr 2021 Ongoing
Ibuprofen and Famotidine Tablets (800+ 26.6 mg) Duexis Ongoing Nov
2020 Mar 2021
Apr 2021
Jun 2021 Ongoing
Bisacodyl Enteric Coated Tablets (5 mg)
Dulcolax DR Tablets
Ongoing Oct 2020
Nov 2020
Dec 2020
Feb 2021 Ongoing
Nefidipine Extended Release Tablets (30mg) Adalat GITS Ongoing Nov
2020 Jan
2021 Feb 2021
Feb 2021
Material Awaited
Artemether + Lumefantine (20+120 mg and 80+480 mg) Riamet Ongoing Nov
2020 Jan
2021 Jan
2021 Jan
2021 Ongoing
Prochlorprrazine Maleate Tablets (5 mg and 10 mg) Procomp Ongoing Nov
2020 Jan
2021 Jan
2021 Jan
2021 Ongoing
Ongoing
Exclusivity for mentioned Region
Stage Completed
Open for Out-Licensing
Perfect Blend of Quality and Economy
FORMULATION DEVELOPMENT List of Products Developed- Updated List as on Oct 2020
Product RLD Used
For Product Development
Development Status
Pilot BE
Scale Up
Pivotal BE
Technology Transfer Remark
Open Market Available for Out Licensing
USA EU China Australia South East Asia
Other
Cysteamine Bitartarate Delayed Release Capsule (25 mg and 75 mg)
Procysbi Ongoing Mar 2021
April 2021
May 2021
Jul 2021 Ongoing
Abiraterone Acetate Tablets 500 mg Zytiga Ongoing Nov 2020
Jan 2021
Jan 2021
Jan 2021 Ongoing
Fluvoxamine Maleate ER Capsules (100 mg and 200 mg)
Luvox CR Capsules Ongoing Dec
2020 Dec 2020
Feb 2021
Feb 2021 Ongoing
Propranolol Hydrochloride ER Capsules (60 mg ,80 mg,120 mg and 160 mg
INDERAL LA Ongoing Nov 2020
Jan 2021
Jan 2021
Jan 2021
Ready for Scale up
Aprepitant Capsules (40 mg, 80 mg and 125 mg) EMEND Ongoing Mar
2021 Apr
2021 May 2021
Jul 2021
Venlafaxin ER Tablets (37.5 mg,75 mg,150 mg and 225 mg)
Effexor Ongoing Mar 2021
Apr 2021
May 2021
Jul 2021
Metformin Extended Release + Dapagliflozin Tablets (2.5/1000, 5/500, 5/1000, 10/500, 10/1000 mg)
XIGDUO XR Ongoing Mar 2021
Apr 2021
May 2021
Jul 2021
Ongoing
Exclusivity for mentioned Region
Stage Completed
Open for Out-Licensing
BACK
ANALYTICAL SERVICES Introduction & Salient Features
Perfect Blend of Quality and Economy
Located in Suburbs of Mumbai, at a distance of about 20 km from Airport
Dedicated to testing of Pharmaceutical Products for Regulated Markets
(USFDA, MHRA, TGA, WHO…)
Highly experienced Technical staff with rich experience into Regulatory
markets.
Process of implementation of Electronic Laboratory Notebooks (ELNB) under
progress for data management.
ANALYTICAL SERVICES Objectives
Perfect Blend of Quality and Economy
To provide efficient and accurate quality services to our customers.
To impart appropriate training to enhance our employee's competency.
To reduce sample handing and processing time to ensure prompt and on
time analytical results.
To receive feedback from customers and address grievances efficiently.
To enhance customer satisfaction and to reduce customer complaints.
ANALYTICAL SERVICES Capabilities
Perfect Blend of Quality and Economy
Analytical Method Development
Analytical Method Validation
Biowaiver studies
Process Validation
Stability Study
Residual solvents
Impurity Characterization &
Profile
Dissolution Profile
Tablets, Capsules (Hard & Soft gel)
Oral Liquids
Ointments, Gels & Creams
Topical Powders
Liquid/Dry powder Injectables
Lyophilized Injections
Other items such as APIs,
Excipients and other formulation
& additives
F O R
ANALYTICAL SERVICES Infrastructure
Perfect Blend of Quality and Economy
Instrument Name Make Model No. Of Instrument
LCMS/MS Shimadzu LCMS-8045 1
HPLC (UV/PDA) & UPLC Waters Alliance e2695 5 & 1
GC-HS (FID) Agilent 7890B/7697A 1
Dissolution Tester Electrolab EDT-14LX 4
FTIR Jasco FT/IR-4600 1
UV Spectrophotometer Shimadzu UV1800 1
Walk-in Stability chambers (Total Capacity: 1,00,000L) Newtronics NLWH555SU 5 (ICDAS Software)
Auto-titrator Metrohm 907 titrando 1
Ultra micro analytical balance Mettler Toledo XPE26 1
Semi-Ultra micro analytical balance Radwag XA210.4Y.A 1
Water purification system Milli Q & Adrona Q-Front 2
Glassware cleaning machine Lancer 820 LX 1
ANALYTICAL SERVICES Accreditations
Perfect Blend of Quality and Economy
ANALYTICAL SERVICES Glimpses
Perfect Blend of Quality and Economy
ANALYTICAL SERVICES Glimpses
Perfect Blend of Quality and Economy
ANALYTICAL SERVICES Glimpses
Perfect Blend of Quality and Economy
ANALYTICAL SERVICES Glimpses
Perfect Blend of Quality and Economy BACK
E-Mail: [email protected] [email protected] Mobile: +91-6280918142 +91-9131925456 Website: www.indivrtus.com LinkedIn: linkedin.com/in/upendra-jain-
15323713
CONTACT US
Perfect Blend of Quality and Economy