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Our Services
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.
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 | 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.
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