Regulatory Affairs Service
JSC "Corpus Medica" supports pharmaceutical companies and provides Regulatory, Pharmacovigilance and readability testing services for our partners:
- Sopharma PLC, Bulgaria, since 2000
- SC „Concern Stirol“, Ukraine, since 2003
- JSC „Pharmstandard-Leksredstva“, (former ICN-Leksredstva), Russia, since 2004
- Salts Healthcare Ltd., UK, since 2005
- IVAX Pharmaceuticals s.r.o./TEVA, Czech Republic /UK, 1998-2006
- Ranbaxy (UK) Ltd., 2001-2009
- Genericon Pharma Gmb.H., Austria, since 2007
- OlainFarm, JSC, Olaine, Latvia, since 2007
- PT. Novell Pharmaceutical Laboratories Ltd., Indonesia, since 2007
- Sanofi-Aventis Lithuania Ltd., since 2008
- Ingen Pharma Ltd., since 2010
Our services:
- Organization and monitoring of Authorization procedure in Lithuanian State Medicines Control Agency (SMCA)
- Authorization of Medical Devices and Food supplements in Lithuanian Ministry of Health
- Generation, translation and adjustment of Patient Information Leaflets (PIL), SmPC (Summary of Product Characteristics), mock-ups to the requirements of the Lithuanian SMCA
- User Testing (Readability Testing) of PIL; preparation, testing, translation and report submission
- Transfer of marketing authorization
- Variations - submission and monitoring
- Generation of Quality Overall Summary, Non-Clinical Overview and Clinical Overview
- Pharmacovigilance service
- Generation of expert reports on pharmacoeconomics for reimbursement procedure in Lithuania
- Other
