Dossier services –For more than 90 countries

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Mydossier.in

Our facility

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

About usMYdossier is a global leader in regulatory consulting and dossier

solution for export registration. We write and review dossier as per

European CTD / ASEAN CTD / non-CTD (country specific

guideline).

What we do:-

Dossier – writing and review

DMFs – writing and review (also draft for formulation dossier

development in filing form)

Analytical method validation (at in-house lab)

Module 4 & 5 drafting (Literature based)

ASEAN CTD & CTD dossiers

PSUR, stability, process validation and drafting

Patent service

Countries:- Asian, CIS, African, Latin American

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Zodiac PharmaLocation

Zodiac Pharma ,

Plot No. 63, 76 & 77,

Industrial Park (APIIC) Valasapalli,

Madanapalle -517 325,

Andhra Pradesh India

Email:- info@zodiacpharma.com

We had prepare more than 5000 product

registration dossiers for more than 54 countries.

Format:- CTD (ASEAN & EU) & Non-CTD (updated on Jan 2016)

And we are capable to make dossier for more than 90 countries.

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Facility Total Area:- 30,000 sft (Thirty thousand square feet)

Constructed Area (for dossier services):- 10,000 sft (Ten thousand square feet)

It is one of Leading dossier facility in India

CER (Corporate Environmental Responsibility):- More than 150 plants witthin our facility ( 1 plant per 18 sqm)

CSR (Corporate Social Responsibility):- We also share our part of profit to children education (poor)

We are having below facility:-

1. Sophisticated Instrument (HPLC, Dissolution and

DT apparatus) Room

2. Testing & working Lab

3. Helpdesk / reception

4. Conference Hall

5. Meeting Room

6. Demo Room

7. Library and Documentation Room

8. Sample Storage Room

9. Lounge - for rest and relax

10.24 X 7 UPS backup

11.Parking facility

12.CCTV (for security) and Biometric system (for

accessing facility)

This facility is under CCTV surveillance. We issue one

identity card & electronic card, by which working

employees / clients can enter and access the

MYdossier facility.

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

VISIONZodiac Pharma aspires in achieving significant business in generic product dossier &

research consultancy with a strong presence in EUROPE, semi-regulated and non-

regulated market (Asia, Africa, CIS, Latin America)

Complete & updated database and reference MoH approved dossier

Regulatory expertise -Dedicated professionals (Knowledgeable & Experienced)

High quality @ reasonable price (Cost effective services)

Confidentiality

On-time delivery

Complete dossier solution

Complete regulatory assistance upto the product registration stage

Since 2008, Over 8 years of experience in global regulatory environments

In-house Testing Facility for AMV with data bank of MoA & chromatograms

Troubleshooting expertise

WHY ZODIAC

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Our Services

Dossier – writing and review

DMFs – writing and review (also draft for formulation dossier

development in filing form)

Analytical method validation (at in-house lab)

Module 4 & 5 drafting (Literature based)

ASEAN CTD & CTD dossiers

PSUR, stability, process validation and drafting

Patent service

Countries:- Asian, CIS, African, Latin American

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Dossier Service

Administrative Documentation (writing and review):-

Registration Application & Covering Letter

Letter of Authorisation

Legal & Administrative (GMP,CoPP, FSC etc) Documents

Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert

Label and carton contents

Global Patent Information and Literature for patented product

PSUR (Periodic Safety Update Reports)

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Dossier Service

Technical Documentation (writing and review):-

Summaries - Quality, Clinical & Non-clinical

Drug master file (S Part of Dossier)

Clinical & Non-clinical Overview (Module 2)

PDR, Process validation, AMV & Stability Studies

Specification, Method of analysis & Certificate of Analysis of Raw materials &

Packing Materials

Specification, Method of analysis & Certificate of Analysis of Formulation

product

Module 4 (Non-clinical)

Module 5 (Non-clinical)

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Drug Master filesAdministrative Documentation (Writing and Review):-

Registration Application, Letter of Authorization & Covering Letter

Legal & Administrative Documents

Transmittal letter

Global Patent Information and Literature for patented API

Patent infringement analysis

Technical Documentation (Writing and Review):-

Summaries - Quality (2.3.S part)

Drug master file (open and closed part)

Manufacturing and Characterization part of DMF

Process validation, AMV & Stability Studies

Specification, Method of analysis & Certificate of Analysis of Raw materials

Specification, Method of analysis & Certificate of Analysis of API

We had prepared more than 1850 DMFs.

We can also prepared S-Part of CTD for formulation dossier submission (CTD / ACTD).

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Module 4 & 5MODULE 5 CLINICAL STUDY REPORTS

5.1 Table of Contents

5.2 Listing of All Clinical Studies

5.3 Clinical Study Reports

5.3.1 Biopharmaceutics Reports

5.3.2 Studies Pertinent to Pharmacokinetics

using Human Biomaterials

5.3.3 Human Pharmacokinetics

5.3.4 Human Pharmacodynamics

5.3.5 Clinical Efficacy and Safety Studies

5.3.6 Reports of Post-Marketing Experience

5.3.7 Case Report Forms and Individual Patient

Listings

5.4 Literature References

MODULE 4 Non Clinical Study Reports

4.1 Table of contents

4.2 Study Reports

4.2.1 Pharmacology

4.2.2 Pharmacokinetics

4.2.3 Toxicology

4.3 Literature References

We also make clinical and toxicology studies (non-

CTD format) as per ROW countries

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

PSURMYdossier is a global leader in regulatory consulting and Periodic Safety Update

Report (PSUR) solution for export registration in CIS and other countries. We write and

review Periodic Safety Update Report as per European CTD guideline. Periodic Safety

Update Report includes:

1. Worldwide marketing authorization status

2. Overview of exposure and safety data

3. Actions taken in the reporting interval for safety reasons

4. Changes to reference safety information

5. Estimated exposure and use patterns

6. Summaries of significant findings from clinical trials in the reporting interval

7. Findings from non-interventional studies

8. Information from other clinical trials and sources

9. Non-clinical data

10. Literature

11. Discussion and conclusions on PSUR data

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

AMVMYdossier offers complete analytical method development, method validation and transfer services through a

dedicated staff of knowledgeable and experienced pharmaceutical scientists. MYdossier has experience in support

of various dosage forms within the generic and branded pharmaceutical industries. We perform validation as per

ICH guideline, which is acceptable to MOH/FDA of Asian, African, CIS, Latin American and rest of world. We also

handle all queries related to validation which is raised by MOH/FDA.

Validation Services for:-

Assay - Method validation

Dissolution - Method Validation

Related Substance (impurities) - Method Validation

Identification - Method Validation

Products:- Pharma Formulation, Bulk (API), Food & Veterinary

Analytical validation: - As per ICH / ASEAN / WHO / other country specific guideline

HPLC used for Validation:- Shimadzu LC-2010 (Fully automated with most advanced

technologies) – ITS AVAILABLE AT OUR OWN SITE

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Supportive Services We are providing below services:

SmPC, PIL, Label and pack insert - writing / review as per MOH guideline

Translation of documents (in 50+ languages)

Product literature and Readablity testing

Artwork Desiging

Patent services

BA/BE studies - monitor and co-ordinate (with CRO)

Process validation and stability studies - protocol, report and chromatograms

We are capable to prepare dossier for more than 90 countries.

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Strategic Planning

We provide services for strategic planning for product development and

registration. Successful registration approvals and timely product launches

begin with sound strategic planning during the early development stages.

Our Services:

Advising on suitable regulatory strategy

Suggesting the finest route to the market

Dossier Management for multiple countries registration

Sketch up project plans

Monitoring the project till product registration

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Patent Service

We are preparing dossier for patented and non-patented (generic) products.

And we provide below patent services:

Global Patent Information

Literature for patented product / Innovator product

Non-infringing process – Analysis

Non-infringing report

Patent review

Patent search

Prior art search

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

BA/BE ServiceWe are allied with well recognized and reputed study centres which are

approved from local regulatory body (DCGI) and other regulatory

authorities (USFD, MHRA etc), to carry out BA / BE studies of

various dosage forms:

We assist customers to carry out the BA / BE studies in the above

mentioned study centres. We also involved for monitoring and

liaisoning with the CRO's for BA / BE Studies.

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Our Philosophy - QualityMaintaining highest quality standards is the foundation of

Mydossier’s Regulatory and Analytical Services.

We believe that the success of any organization depends

primarily on its human resources. Our committed and highly

skilled professionals always guided us towards newer

achievements and set a route for the bright future.

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Countries – (for dossier services)Asia

Afghanistan

Bangladesh

Cambodia

China

Hong Kong

India

Indonesia

Iran

Iraq

Jordan

Lebanon

Mongolia

Malaysia

Myanmar

Nepal

Papua New

Guinea

Philippines

Saudi Arabia

Singapore

Sri Lanka

Syria

Thailand

Turkey

Vietnam

Yemen

Africa

Algeria

Benin

Botswana

Burkina

Faso

Cameroon

Chad

Congo

Egypt

Ethiopia

Gabon

Gambia

Ghana

Ivory Coast

Kenya

Madagascar

Malawi

Mali

Mauritania

Mauritius

Mozambique

Namibia

Nigeria

Niger

Senegal

Sudan

Sierra Leone

Tanzania

Togo

Uganda

Zaire

Zambia

Zanzibar

Zimbabwe

North

America

South

America

Central

America

Argentina

Bolivia

Chile

Costa Rica

Cuba

Dominican

Republic

Ecuador

El Salvador

Guatemala

Guyana

Haiti

Honduras

Jamaica

Mexico

Nicaragua

Panama

Peru

Suriname

Trinidad

Uruguay

Venezuela

CIS

countries

Azerbaijan

Belarus

Georgia

Kazakhstan

Kyrgyzstan

Russia

Tajikistan

Turkmenista

n

Ukraine

Uzbekistan

Europe &

Others

Armenia

Bulgaria

Estonia

Moldova

Romania

Spain

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

Founder

Mr. Tara chand Tak is founder and CEO of MYdossier. His foresightedness can be well showed by his

endeavors which area from Pharma dossier sale, regulatory affairs, handling MOH inquiry, and dossier

training for small to medium size pharmaceutical companies to help them to overcome the challenges

within the rapidly evolving global pharmaceutical market.. He drives the company's vision, strategy and

growth as it provides interesting and unique ways for client and learner to serve their purpose.

He did his schooling from Jawahar Navodaya Vidyalaya (Pali) Rajasthan. He did his

B.Pharm & M.Pharm from Manipal collage of Pharmaceutical Sciences, Manipal University, Udupi,

Karnataka. He also did certificate course in intellectual property rights from World Intellectual Property

Organization (WIPO), Geneva, Switzerland. He Qualified GATE Examination (conducted by IITs &

IISc) with ALL INDIA RANK 198.

After his postgraduate, he worked on the post of Executive in Pharma MNC companies at

Bangalore and Hyderabad. His core areas of during job were in dossier writing, global dossier

management and international marketing. During that period, he got opportunity to work with global

leader – Pfizer, Ranbaxy, Sandoze, Teva, Lupin, DRL, Mylan, Stride arcolabs, Apotex Canada etc.

We have more than 50 satisfied clients in India and out-side India.

We are capable to prepare dossier for more than 90 countries.

www.mydossier.in

For further information contact us @

MYdossier.in

Dossier Consultancy Division,

Zodiac Pharma

Plot No. 63, 76 & 77,

Industrial Park (APIIC) Valasapalli,

(On Sate Highway No 219),

Madanapalle -517 325,

Andhra Pradesh India

Website:- http://www.mydossier.in

Email:- dossier@zodiacpharma.com

CALL, SMS or Whatsapp to

+91-965-22-81-81-4

Landmark:- Punganur road (State Highway No

219) Juice Factory >> Esser petrol Pump

Google Map:- TYPE keyword "Zodiac Pharma" or

"Zodiac Pharma madanapalle"

Google Map link:- Click here>>