Medlex Baltics

Medlex Baltics has sound experience in Regulatory Affairs (maintenance of Marketing Authorizations, drawing up documentation for registration of MP), health economics, pharmacoeconomic calculations, pricing and reimbursement systems in Europe, Pharmaceutical products wise marketing, Food Supplements, Veterinary Medicines, Pharmacovigilance and Life science Translations. We provide you with 24/7 Pharmacovigilance services and corrective and preventive actions helping to ensure drug safety for a complete Pharmacovigilance system, we will help you to draw up standard operating procedures, as well as ensure electronic reporting to Eudravigilance system. Medlex Baltics can be of assistance with a Qualified Person for Pharmacovigilance and preparing risk management plans. Electronic reporting of Suspected Unexpected Serious Adverse Events. Pricing and Reimbursement and health technology assessment in European Union. Communication with local Regulatory Authorities and Health Authorities (Zāļu valsts aģentūra (State Agency of Medicines of Latvia)), National Health Service, State Healht Inspection, Ravimiamet (Estonian Agency of Medicines), Lithuanian Agency of Medicines and Pharmaceutical Lobbying. Parallel Import and Parallel Distribution of Medicinal products, Drawing up Documentation. Life Science and Legal Translations of Regulatory documentation (SmPCs, PILs, Labelling, etc.), Clinical Trials documentation (ICFs, Patient diaries, Synopsis, etc), Agreements with Investigators and Study personnel, etc. Food Supplement notifications in Food and Veterinary Service, Cosmetic Products registration in CPNP.