Billev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
Our experts are trained to cover international inspections in the areas of PhV, GxP, which have become of an all increasing importance in Pharmaceutical industry.
Our team that consists of:
- PhD in Pharmaceutical Sciences
- M.Sc. in Pharmaceutical Sciences
- Medical doctor (MD in Pharmacology, Master of Research (MRes) in Biomedical Sciences, MBBS (Bachelor of Medicine and Bachelor of Surgery)
- Doctor of Veterinary Medicine
is working with all EU national competent authorities and EMA and has expertise in areas covering regulatory affairs, pharmacovigilance, medical affairs and quality assurance.
We are actively involved in influencing the legal development work in EU. Further we receive access to key information in time that our customers can benefit from this in their strategic planning. This we do through membership in Medicines For Europe Association (former EGA):
- Regulatory and Scientific Affairs Committee
- European Market access Committee
- Quality and Compliance Working group
- Pharmacovigilance & Drug Safety Working group
- Bioequivalence Working group
- Telematics Working group
We are regularly present on the face-to-face meetings, tecleconferences, contributing to the position papers and providing comments to consultation papers.
We are also regularly present on the meetings with European Medicines Agency, National Competent Authorities and other Stakeholders.
We are participating as Speaker at international conferences.