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Regulatory

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 :

http://ec.europa.eu/health/documents/eudralex/index_en.htm