Independent medical consultants since 1986 based on more 
than 30 years experiences in pharmaceutical, herbal and 
medical device industries concerning quality, safety and 
efficacy documentation.

We have performed consultancy work for more than 50 
companies, NGO´s and government institutions in Scandinavia, 
but in Denmark mostly. We work in liaison with professional 
associations and EU partners which often provide added value 
to our clients.

We have 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. 
We also ensure maintenance of the MA.
We also have a long history in the preparation of clinical 
trials in accordance with ICH/GCP guidelines. We work in 
compliance with our own GCP/SOP´s unless the sponsor want 
different standard operating procedure. We provide the 
planning, regulatory and etics committee handling, 
investigator recruitment, monitoring, data management and 
the final clinical report. We utilize now more often 
investigator and monitoring partners from the EU applicant 
countries.

We do also provide regulatory assistance to firms within 
development, production or sales of herbal medicine, 
pharmaceuticals, dietary supplements, functional food and 
medical devices. 
Core competencies:

Herbal Medical Product and drug registrations in EU (GMP, 
GLP, GCP standard). 

Conduct clinical trials (GCP standard). 

Documentation and advice on cultivation of medical plants 
(GAP standard). 

Develop market evaluations and business plans. 
Key Areas
Cardiovascular Disease, Clinical Protocols, Clinical 
Testing, Drug Potential, Endocrinology, Gastrointestinal 
Disease, Geriatrics, Immunology, Monitoring Tools, 
Pharmacology, Therapy, Toxicology, Treatment.