ELM Farmacéutica

MEDICINAL PRODUCTS

From development to marketing Development Dossier in European form Marketing authorization in UE Marketing Meetings for scientific advise Strategy and tracking Tracking price and reimbursement Registration dossier and European legislation Transfer: Distributors, manufacturers Market vigilance Clinical trials Quality and Manufacturing Coordination Facilitate/Support

TRAINING

Advice and monitoring clinical trials Application for authorization of clinical trials both national and European Advise and monitoring clinical trials Scientific advice Agencies meeting preparations Meeting with the Agency prior registration dossier Preparation of the meeting Coordination Preparation final report

Registration dossier Preparation registration dossier in eCTD and NeeS format. Medical Writing Due diligence Slot application Meetings with European agencies Legal advice

Strategy and tracking Evaluation of the best strategy according your needs from the submission of the dossier to European approval. Facilitation in all legal and fiduciary matters within the European Union. Price and Reimbursement Price request management, reimbursement with Social Security charge

Pharmacovigilance QPPV (local and EU) SOPs Pharmacovigilance system master file PSUR ICSR Bibliographic search Post Marketing Surveillance ………

Complete control during its life cycle  Variations: Type IA, IB y II  Revalidation  Annual fee  MAH transfer  Product information  Scientific service  Readability test

MEDICAL DEVICES

Medical Devices Product registration in Europe, CE mark obtention, Marketing communication Clinical report according to MEDDEV Market vigilance Facilitate contact licences for manufacturers, importers Distribution licence

COSMETICS

Cosmetic and Product for Hygiene  Declaration responsible for manufacturing and/or importing  Communication CPNP portal  PIF (Product Information File)  Tests advise (challenge test, patch test…)  Cosmetovigilance Product for hygiene dossier and market vigilance

FOOD SUPPLEMENTS

Food supplements  Brussels registration  Communication the start of marketing  Registration of companies  Market vigilance

OTHER SERVICES

Other services…  National code request  Companies registration (distributors, laboratories)  Import and export to Europe: legal procedure (CPP…)  Advise and SOP preparation for distribution companies, manufacturing, marketing cosmetics, dietary supplements, medical devices

Contact: ELM Farmacéutica Valencia 231, Ático 2ª Barcelona Phone: Fax: