EPMC Pharma will help you to bring your medicinal products faster on the market
EPMC Pharma, a newly created private Company based in Brussels (Belgium), offers expertise in European Medical, Pharmaceutical and Regulatory Affairs.
What can offer EPMC Pharma ?
· A team of highly qualified professionals (Lawyers, MDs, PharmDs, PhDs, ... ) with significant experience in big Pharma Companies, Regulatory Agencies and Universities
· A network of the best European Experts specialised in Medicinal Product Development, Regulatory Affairs and R&D Strategies
· A group of lawyers specialised in Pharmaceutical Law, Intellectual Property, Patents and Supplementary Protection Certificates
· Selection of highly qualified personnel in the field of Medicinal Product Development
· Access to European Research Networks:
Ø Pharmaceutical Development
Ø Clinical Research
How will EPMC Pharma help you to facilitate the access to the market of your medicinal products?
· Designing Product Development Plans
· Optimising Regulatory Strategies
· Facilitating the Pharmaceutical Development
Ø Innovative formulations and presentations
Ø Preparation, submission and follow·up of Clinical Trial Applications
Ø Access to Clinical Research networks
· Preparing and organising European Regulatory Procedures
Ø Scientific Advice
Ø SME designation
Ø Orphan Drug Designation
Ø Marketing Authorisation Procedures
- Centralised Procedure
- Decentralised and Mutual Recognition Procedures
· Providing legal advice on issues related to Pharmaceutical Law, Intellectual Property, Patents and Supplementary Protection Certificates
Ø Focusing on Development of Medicinal Products for Paediatric Use
Ø Scientific Advice for Paediatric Development
Ø Paediatric Investigation Plans
· Preparation, submission and validation at the EMEA
Ø Clinical studies in children
Ø Paediatric Use Marketing Authorisation (PUMA) Applications
Ø Submission of applications for the incentives offered by the new European Paediatric Regulation
For further information, please contact:
Jean-Pierre Osselaere, PhD
Managing Director, EPMC Pharma
Associate Professor
College of Pharmacy and Biological Sciences University of Lille 2 (France)
Postal address : Waterhoenlaan, 5 B-1860 Meise (Belgium)
Phone: +32 475 740556
Fax: + 32 2 2702618
E-mail: info@epmc-pharma.com