Pharmaceutical Regulatory Consulting

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

 
Clementi & Associates
Provides regulatory and project management services for pharmaceutical and biotechnology companies.

 
James Harris Associates, Inc
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries.

 
IDRAC
Pharmaceutical Regulatory Affairs database, offers information both on CD-ROM and on-line. Information on legal and administrative affairs and quality, safety and efficacy regulations for Europe, the United States, Central and Eastern European c.

 
Dr. Muller- Lierheim GmbH
Consulting services in regulatory affairs, market research and testing.

 
AVAIL
Provider of clinical development, regulatory affairs, licensing and communications consulting services to the pharmaceutical and medical device industries.

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

 
EuTech Scientific Services
Provider of scientific services in the areas of in method development, quality assurance and regulatory compliance.

 
FOI Services, Inc.
Facilitate access to Food and Drug Administration and other U.S. government files, with collection of documents that record the inner workings of the approval and regulation of medical devices, pharmaceuticals, biologics, veterinary products, fo.

 
PRI Group
Specialists in pharmaceutical and healthcare registration strategy, product development, preclinical and clinical research, regulatory support and training.

 
PPD Pharmaco
Has a regulatory affairs staff with a broad range of registration experiences and regulatory authority liaison experience.

 
BritHealth
Company offers drug delivery Technologies and products and Regulatory advice to pharmaceutical companies to register products.

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

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

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

 
CK Business Resources
A range of services for the regulatory affairs professional including electronic distribution of FDA Weekly Enforcement Reports, FDA Product Approval list, FDA Guidance Documents.

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

 
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.

 
MedDRA Home Page of Coding Plus
A virtual service bureau and consultancy which specialises in MedDRA implementation, legacy data conversions, autoencoder support, training, reference development, and contract coding.

 
Integrated Safety Systems, Inc. (ISS)
Specializing in Pre- and Post-Marketing Pharmaceutical Safety and Surveillance

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

 
WF Jackson Associates, Limited
Services in registrations, clinical trial management and contacts within regulatory agencies throughout the world.

 
BioPharm Consulting
Consulting services in clinical trials, regulatory affairs, and medical writing.

 
Kusuri Pharmaceutical Consultants
A consulting organization that offers services in corporate training and pharmaceutical product evaluations.

 
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 .

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

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

 
BioScorpio
Provider of an updated intelligence information, databases, portfolios, and market research reports, featuring new lifescience products and technologies.

 
Eurogentec
Services and products include research tools, genomic services and regulatory consultancy.

 
International Drug Development (IDD)
Experience in EC drugs development and drugs registration , and network of expert correspondents in regulatory affairs in all EC countries

 
HealthIQ
Healthcare Marketing, Reimbursement, Pharmacoeconomics, Medicoeconomics, Regulatory Affairs, Business Intelligence, Training, and Clinical Research

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

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

 
Pharmaffair Inc.
Consulting firm for pharmaceutical, medical device and biotechnology companies in the areas of regulatory affairs and manufacturing.

 
Panafarma Medical Consult AB
Independent consultancy company specializing in natural remedies, herbal remedies and OTC pharmaceuticals, compiling EU abridged applications for market authorization of herbal remedies and OTC pharmaceuticals.

 
Beckloff Associates, Inc.
Assisting clients in bringing new pharmaceutical products to market, by developing efficient scientific regulatory strategies that reduce the overall development time for new pharmaceutical products

 
The HST Consulting Network GmbH
Provides global regulatory strategies in Europe by coaching and cooperating in all parts of this process. Based in Switzerland.

 
Jarosz Regulatory Services
Regulatory Strategies, Expert Reports, Clinical/Preclinical Overviews, CTX/IND, Plant Master Files, and Drug Master Files are just some of the services provided.

 
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.

 
Institute for Validation Technology
Based in Florida, serves validation and compliance professionals in FDA-regulated industries through the development of academic journals, timely educational conferences and exhaustive documentation.

 
INCAD, Inc.
Provides a full service 'FDA' regulatory reference information center for research and training.

 
McCulley/Cuppan LLC
Provides a variety of solutions to the biopharm industry for resolving document development problems to meet global regulatory expectations and business demands.

 
Career Marketing Associates
Specializing in Toxicology, Product Safety and Regulatory Affairs disciplines.

 
Bright & Associates, Inc.
Consulting firm serving the medical device, pharmaceutical and related industries in specialized areas of regulatory affairs and quality assurance.

 
Novotech Communications
Based in Australia, regulatory and scientific affairs services to both local and internationally based clients.

 
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.

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

 
Medical and Regulatory Affairs Services
Providing assistance to domestic and international Pharmaceutical Industries in the area of clinical research and regulatory affairs.

 
MJW Corporation
Provides a wide variety of radiological consulting services as well as software solutions for health physics and other technical applications.

 
The Medical Dictionary for Regulatory Activities
MedDRA has been developed as a pragmatic, clinically validated medical terminology with an emphasis on ease-of-use data entry, retrieval, analysis and display, with a suitable balance between sensitivity and specificity, within the regulatory en.

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

 
Scandinavian Regulatory Services
Based in Scandinavia, with services including development of regulatory strategies, project management, development of dossiers, national applications, mutual recognition and centralised applications.

 
Asphar Consulting
An Argentinean-based consulting company, that develops services in three main areas, strategic business, technical services and regulatory affairs.

 
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.

 
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