Home : Project Management       
Strategic Trial Planning

Project Management

Clinical Monitoring

Data Management and Bios

Marketing Authorisations

Drug Registrations

Cultivation of Medical Plants

Market Evaluations and Business Plans

Medical Writing

Quality Assurance

Outsourcing


Regulatory Affairs in Denmark

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EMPAS - A long story...

EMPAS was founded as a Medical Consultant Organisation in 1986 and is based on more than 30 years experiences in Pharmaceutical, Herbal and Medical Device Industries concerning quality, safety and efficacy documentation.

EMPAS is founded ad run by Bjarne Fredberg Knudsen. His proffesionnal experience combined with highly skilled independend proffesionals from all over Europe creates the modern EMPAS. 



EMPAS has extensive and long experiences in the creation of abridged applications for marketing authorisations (MA) of OTC pharmaceuticals and herbal medicinal products. We evaluate documents, compile dossiers, prepare and evaluate expert reports to be in compliance with CTD guidelines, and we prepare national and centralised applications. We take care of mutual recognition procedures and variations applications.
 
   
Fields of expertise:
Strategic Trial Planning
Project Management

Clinical Monitoring
Marketing Authorisations
Drug Registrations
Cultivation of Medical Plants
Market Evaluations and Business Plans
Data Management and Bios
Medical Writing
Quality Assurance
Outsourcing
Gamma Images
Medical Devices
Regulatory Affairs in Denmark

Key Areas

Cardiovascular Disease, Clinical Protocols, Clinical Testing, Drug Potential, Endocrinology, Gastrointestinal Disease, Geriatrics, Immunology, Monitoring Tools, Pharmacology, Therapy, Toxicology, Treatment.