Pharmaceutical Quality Assurance Consulting

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Validation Services
Quality / validation engineering and software services.

 
Schafer Veterinary Consultants
Worldwide consulting services to the veterinary pharmaceuticals and biologics industries. Based in Colorado.

 
Arthur M. Horowitz & Associates
Consulting in the field of FDA regulations, standard operating procedures, documentation, and training.

 
Noblitt & Rueland
FDA GMP, QSR, Design Control, software development, software validation, V&V, risk, hazard, submissions, 510(k), IDE, PMA, consulting and training.

 
KMI/PAREXEL
Compliance Consultants and Quality Systems Specialists provide the resources and experience to design, develop, modify, and implement GMP-related processes and systems.

 
Validation Masters, Inc.
Customizes a validation program for a particular application, process or facility, providing an individual service or a fully integrated combination.

 
TechniPharm Consulting Group
Versatile engineering and scientific team with expertise in the pharmaceutical and biotechnology industries.

 
Topaz Technologies
Based in Austin, Texas, provider of custom software, commercial software products, and consulting services for regulated markets.

 
DevStrat Group Consulting Alliance
A consortium of independent consulting specialists that offers experience and expertise in a number of functional areas for the development and operation of biotechnology, pharmaceutical and medical device companies.

 
ACERNA Inc.
A Canadian pharmaceutical, biological, and medical device consultancy which provides regulatory affairs and Good Manufacturing Practice services.

 
Biovantage Consulting
Provides regulatory support to medical device, pharmaceutical and biotechnology industries with a focus on FDA, GMP and ISO 9000 requirements.

 
Pharmaceutical Consultants
Provides services to the pharmaceutical and biopharmaceutical industries, regarding quality management and regulatory affairs.

 
Drug & Device Development Co.
Services to help comply efficiently with FDA requirements.

 
Pharmaceutical Services Corporation
A company specializing in validation, regulatory issues, compliance, calibration, and temporary laboratory services.

 
Fantasia Consulting Associates
Providing regulatory affairs and quality management of medical devices, pharmaceuticals, biologics, and biotechnology.

 
Honeyman Associates Pharmaceutical Purity Water Systems
Specialist consultancy based business, operating principally in the field of high purity water systems for the Pharmaceutical Industry.

 
mdi Consultants
A FDA, IVDD, CE mark, HACCP, ISO9000, GMP, compliance consulting company for the medical device industry. Based in Great Neck, New York.

 
The Weinberg Group
Helping businesses improve manufacturing processes, clear regulatory hurdles, defend products in courts and the media.

 
Waldman Biomedical Consultancy
Complete FDA compliance and regulatory support worldwide to manufacturers of biologicals, drugs and devices.

 
Validation Associates, Inc.
Provides the pharmaceutical, biotechnology, and medical device industries with Computer System Validation Project Consulting and Training Services.

 
Quadrants Scientific Inc.
Specializing in regulatory and quality consulting to the FDA regulated industries. Located in San Diego, California.

 
SBS Pharmaceutical Validation Services
Consulting services in pharmaceutical validation projects.

 
Q-One
Provider of safety testing and process validation services, contract manufacturing of cell banks, vaccines and gene therapy products to the biopharmaceutical industry.

 
Validation in Partnership
Located in Cheshire, U.K. Validation services for process, software, and training and SOP implementation.

 
Globpharm
Provides expert consulting services in the areas of GMP and Quality Systems to the worldwide pharmaceutical, biotechnology and medical device manufacturing industries.

 
NutriCeutical Consulting
NutriCeutical Consulting creates and executes validation protocols assuring regulatory compliance for the pharmaceutical, biotechnology and food industries.

 
Lachman Consultants
Expert technical consultation in the areas of FDA Related Activities, Quality Control, Quality Assurance, Validation, Qualification, Stability and Expiration Dating.

 
PharmaSys, Inc
Computer validation, equipment validation, process validation, thermal validation and FDA GMP compliance for the pharmaceutical, biotech and clinical trials industries.

 
Excel Partnership
International training/consulting provider in business process improvement, ISO9000, QS-9000, TL9000, ISO14000, ISO Guide 25, Measurement and Calibration, Medical Device and other FDA Regulated industries.

 
International Pharmaceutical Services
Core competencies include business development, R&D management, information technolgy and regulatory affairs

 
Waldman Biomedical Consultancy Inc.
FDA compliance and regulatory support worldwide to manufacturers of biologicals, drugs and devices.

 
Cornerstone Pharmaceutical Consulting
Specializes in CGMPs for the BPC/API industry. Our customers include start-up and virtual companies, contract manufacturers and established pharmaceutical corporations.

 
Quality & Compliance Consulting, Inc
Regulatory compliance issues, incorporating quality systems, and help assure validity and accuracy of regulatory submissions.

 
Polaris Clinical Research Consultants, Inc.
Training and development company that specializes in clinical research topics and processes, providing training, auditing, and Standard Operating Procedure (SOP) development to our clients.

 
mdi Consultants, Inc.
Cosultancy in strategic management concerns including concentration in FDA related matters, quality systems such as GMPs, ISO 9000, ISO 14000, 'CE' Mark for Europe.

 
Regulatory Affairs, North America LLC
Provides services to the pharmaceutical, biotech, and medical device industries in the areas of FDA submissions, compliance, SOPs, product development, and project management.

 
Beardsworth Consulting Group
Provider of clinical research management, data management, quality assurance and medical writing services to pharmaceutical, device and biotechnology companies throughout North America.

 
Global Validation Services
Provider of computer validation and systems assurance services for the pharmaceutical, biotechnology, medical device, nutritional, consumer products and cosmetics industries.

 
ValiCor Associates, Inc.
Full service validation and compliance consulting for the pharmaceutical, medical device and biotechnology industries.

 
William Trilsch & Associates
Quality Assurance and Regualtory Affairs consulting firm serving the biopharmaceutical industries.

 
Validation Technologies
Providing Worldwide Validation, Compliance and Technical Services to the Medical Device, Biotechnology and Pharmaceutical Industries.

 
Emergo Group, Inc.
ISO 9001 registered consulting firm with offices in the United States and Europe, and provides a full range of product compliance, quality assurance and export-related services and training for manufacturers and exporters of medical devices and .

 
Validation Group & Quality Systems Associates
Regional organizations staffed with professionals ready to support your validation, regulatory and laboratory testing project requirements.

 
Eutech
Improve asset productivity, process improvement, validation and regulatory compliance consulting.

 
Bio-Reg Associates, Inc.
Provider of medical and pharmaceutical consulting services. Services include medical device and in-vitro diagnostic consulting services to gain FDA approval. Services are provided to the medical and pharmaceutical industries. This company was.

 
Donawa and Associates
Offices in Italy and Ireland to assist medical device and in-vitro diagnostic companies in meeting US and European regulatory, clinical, technical and quality system requirements.

 
Validapro International
Specializes in validation and regulatory compliance.

 
Automated Systems, Inc.
Wide range of abilities in pharmaceutical process, equipment and facilities engineering, automation, validation.

 
BioAssist
Provides quality systems for product design, manufacturing efficiency, and responsiveness to customers. Consultancy in interfacing with FDA and regulatory bodies.

 
Institute of Validation Technology
Provides educational publications, conferences and other informational products related to validation technology.

 
Diversified Biomedical Technologies, Inc.
Provider of regulatory affairs and quality systems consulting services for clinical systems. Services are provided to multiple industries. This company was capitalized by private investment.

 
Columbia Pharma Consulting Services, Inc.
Provider of drug, OTC, medical device facility evaluations, QC/QA and bioequivalence laboratory operations, regulatory document preparation for therapeutic products, training programs, documentation systems and GMP, GCP and GLP monitoring servic.

 
International Regulatory Consultants
Specialize in helping manufacturers of medical products coordinate North American, European, and Pacific Rim regulatory affairs and quality systems compliance activities.

 
Perigon
Provider of engineering, architectural, project management and validation services to the process and pharmaceutical industries.

 
Booth & Associates
A consultancy which provides technical support in the areas of sterilization, process validation and GMP compliance.

 
BioMetics, Inc.
Provides engineering, design, validation, cGMP consulting and project management services for biopharmaceutical and environmental technology companies

 
Maggid-Haffner Associates
Provider of quality assurance/quality control and regulatory affairs services.

 
Validation & Training Services, Inc.
Based in Massachusetts, provides software and process validation services.

 
Certified Software Solutions
Services include software development, 510(k) preparation and submission, safety risk analysis, verification and validation, and design controls.

 
Cetan Technologies
Provides specialized services for the pharmaceutical, biotechnology, and medical device industries: Computer System Validation (CSV) services, Document Imaging, Standard Operating Procedures (SOPs)

 
CRO Group
Contract organization for medical, biotechnology, and in vitro diagnostic device companies in CE Marking, design and development, clinical trials, QA, regulatory, reimbursement.

 
Kmi-Parexel, Inc.
Provider of FDA compliance and validation services.

 
Medical Device & QA Consultancy
MDD 93/42/EEC 'CE marking' consultancy, QA compliance and documentation review services.

 
Validation Systems, Inc.
Provides complete Validation and Laboratory Services to our clients.

 
BioReg International
Offers FDA consulting services to large and small medical device manufacturers.

 
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