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.
Company Details
- Employees
- 2
- Founded
- -
- Address
- Blaumaņa Iela 38/40-19, Riga,lv-1010,latvia
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- medlexbaltics.com
- Keywords
- Preparing of documentation for receipt of approval for parallel import of medicines and food supplements in Latvia, MAH services in Baltics, notification of cosmetic products in CPNP, Drawing up documentation for submission in EMA for parallel distribution of medicinal products, Medical writing, Pharmacovigilance services 24/7, Regulatory Affairs, Market Access, Pricing and Reimbursement, Medicine, Health, Medical Sciences, Pharmacology, Science and Environment, Pharmacoeconomics, Health economics, Life science translations, Veterinary medicines files preparation.
- HQ
- Riga
Medlex Baltics Questions
Medlex Baltics's website is medlexbaltics.com
Medlex Baltics's LinkedIn profile is https://lv.linkedin.com/company/medlex-baltics
Medlex Baltics has
2 employees.
View email and phone details for 2
employees at Medlex Baltics.
Medlex Baltics's industry is
Pharmaceutical Manufacturing
Medlex Baltics's top competitors are
Dtmedik Estetika,
Gekofar S.r.l.,
Crosp Medical Gmbh,
Positive Medicare,
Pharmalps D.o.o,
Regent Pharmaceuticals Limited,
Zydus Group,
Interlux, Uab,
Natchem,
Inoxis Medical (Medimex).
Medlex Baltics's categories are Pharmaceutical Manufacturing
Medlex Baltics's founding year is 2012
