Over Years Assisting Industries in the Validation and Consulting Service. 12
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
“ “ To satisfy our client’s validations To satisfy our client’s validations needs with a needs with a Time EfficientTime Efficient, , Cost Cost EffectiveEffective and and High Quality ServiceHigh Quality Service.”.”
Our organization of experienced technical and regulatory professionals will provide the most excellent quality validation services available.
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
A breakthrough in consulting & validation services in Puerto Rico.
We are a Puerto Rican company, specializing in validation and quality services ( Auditing, Regulatory Advise, CAPA, Investigation, Management Review, Annual Product Review, others ) for the pharmaceutical and medical devices industries.
Our experience covers a broad range of validation, regulatory, manufacturing and quality services; from early product/process development stage to full scale operation and certification.
We bring to each assignment a team of highly qualified personnel, knowledgeable of the most recent regulatory, audit and technical procedures.
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
Project managementProject management PlanningPlanning ResourcesResources Quality ControlQuality Control
TrainingTraining Regulatory ComplianceRegulatory Compliance
cGMPscGMPs GLPGLP Part 11Part 11 QRSQRS ISO 9000, 13485 & 13488ISO 9000, 13485 & 13488 USP, EP, etc.USP, EP, etc.
Technical ComplianceTechnical Compliance
Technical UnitTechnical Unit Q/A ManagementQ/A Management Business UnitBusiness Unit
MarketingMarketing FinancialFinancial Account ReceivableAccount Receivable Customer ServiceCustomer Service
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
Our Experienced Staff will direct its resources in every project. Thus completing each project in an efficient and effective manner.
TSRDQuality Assurance
& Technical Support
TechnicalEvaluation
ClientValidation Project
TeamSchedule
ProjectScope
TSRDValidation Project Leader
& Validation Team
ValidationProject
Manager
ClientApproval
DocumentDevelopment
ClientEvaluation
IQ/OQ/PQEvaluation& Report
Based onDocumentation
Provided byClient or Contractor
Outside the Project Organization
Construction&
InstallationReferences
RegulatoryCompliance
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
Manufacturing Process Parenterals Products (Aseptic Processing, Terminal Sterilized), Solid Dosage, Semi Solid Dosage, Bulk Chemical, Medical Devices (Class I, II & III ), Biotechnology Products and Aerosols.
Methods & Laboratory Analytical Methods, Laboratory Instruments, Management, Microbiological Instrumentation Methods.
Equipment HVAC’s System, Process Equipment ( Parenterals, Solid & Semi Solid Products, Aerosols, Liquids and Medical Devices ) Packaging ( I.e. Blister Machines, Labelers, Others ).
Utilities Water, Compressed Gases ( i.e. Air, Nitrogen ), Dust Collections Systems, Cryogenic System, Refrigeration Systems.
Control Systems PLC’s, Integrity Testers, Building Management Systems, Computer Validation Calibration & PM Management Systems.
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
Facilities Clean and Controlled Rooms, Manufacturing, Cleaning, Packaging, and Laboratories Facilities.
Quality Management Gmp Audits, Mock Inspections, ISO surveillance program, Supplier Certification, Statistics, TQM, ISO 9000, 14885, 14888, Training / Seminars, Regulatory Consultant.
Sterilization Process Sterilization Process for Parenterals Products and Medical Devices (ETO, Dry Heat, Moist Heat, Radiation, and Filtration), SIP.
Other Processes Component Preparations, Cleaning Validation, CIP.
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
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Parke-Davis Pharmaceuticals
Warner Lambert, Inc.(Actually Pfizer)
OMJ Pharmaceuticals
Janssen Pharmaceuticals
Ocular Sciences Puerto Rico, Inc. (Actually Cooper Vision)
Schering Plough Pharmaceuticals
Lilly Del Caribe, Inc. (Mayagüez)
Mentor Caribe(Actually, CIBA Vision)
Company
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
Company
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Reedco and Dentco, Inc
ElectroBiology
Zimmers, Inc.
Allergan
PACO, Inc.
Life Scan
Sartorious, Inc.
Amgen, Inc.
Eli Lilly
Warner Chilcott
Cardinal Health
Heyer-Shulte NeuroCare (Actually, Integra NeuroSciences P.R. Inc.)
Guidant
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
Company
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GlaxoSmithKline
Tyco HealthCare
Boehringer Ingelheim; contracted by AAC Consulting Group
Abbott Laboratories
PALL
Roche
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
2002 2003 2004
5,483 Hours
16,422 Hours
20,786 Hours
Our Standards in Quality has Lead us to Increase Working Hours Year after Year
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
2005
31,820 Hours
2006
24,154 Hours
Where:
Q = High Quality E = Experienced, Trained Personnel
r = Lower Rates t = Timely Service
Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved
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