Pharmaceuticals - Ankara, Ankara Province, Turkey
OUR FACILITIES1. Registration • Arranging drug registration application dossiers in required CTD format and in standards of Ministry of Health. • Converting drug registration dossiers (including those which were previously licensed) from NTA to CTD format.• Arranging borderline product registration application dossiers in accurate borderline product dossier format. • Competing with time for owner of registration application; Presenting professional consultancy facility of whole registration (starting from preparation of registration dossiers to licensing stage).2. Pharmacovigilance 3. Organization of Bioavailability –Bioequivalence studies 4. Pharmaco- Economy: (Pricing and Refunding)5. Audit6. Consultancy • Consultancy facilities on regulations, registration, quality, GMP, GLP, GCP practices, pharmacovigilance and other technical subjects on which knowledge is required.
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