Regulatory Affairs : Highly differentiated meeting of leglislation needs, competitive meeting of timelines
Pharmanel‘s Regulatory affairs experts’ team has established a unique platform, enabling to support and maximize the commercial potential of the pharmaceutical products of the company. They have extensive knowledge of the current legislation, high understanding of regulatory due-diligence and legislative hurdles and experience in Regulatory Affairs Strategies around the world (Europe, Russia, Canada, China, MENA countries, SE Asia )for all the aspects of pharmaceutical products’ life-cycle:
- Preparation of eCTD applications of Modules 1-5 for Marketing Authorization applications and Post-marketing applications (variations and renewals) through MRP/DCP and national procedures
- Pricing support and Product reimbursement support
E.O.F : http://www.eof.gr/
Heads of Medicines Agencies : http://www.hma.eu/
Ministry of Health : http://www.moh.gov.gr/
SFEE - Pharmacovigilance: http://www.sfee.gr/
European Medicines Agency : http://www.ema.europa.eu/ema/
European commission /Public Health :