|Industry||Clinical Research, Regulatory Affairs, Pharmacovigilance, Lithuania, Latvia, Estonia, Belarus, Georgia, Ukraine, Russia, Poland, Eastern Europe, CIS, Full-service, Clinical services, Site management, Marketing Authorization, and Medical writing|
|Headquarters|| 109 Savanoriu ave.
LT-44208, Kaunas, Lithuania
|Number of employees||51-200 employees|
Biomapas is a full-service clinical research organization (CRO) providing Phase I-IV Clinical Research, Regulatory Affairs, Medical Writing and Pharmacovigilance services for the pharmaceutical, biotech and medical device industries. Our expertise spans through various therapeutic areas, such as oncology, CNS disorders, cardiovascular diseases, rheumatology, pulmonology, cardiology, dermatology, etc. Our mission is To combine the strength of our expertise, experience, and high quality deliverables to advance clinical development, market access and post-approval support to the Pharmaceutical and Medical Device industries improving health of patients.
2001 - BIOMAPAS CRO establishment in Lithuania.
2002 - Launch of Phase I-IV Clinical Research Services in Baltics
2003 - First Clinical Trial in Belarus
2004 - Clinical Trials with Biological/Biosimilar Products
2005 - Launch of Full-Scope Pharmacovigilance Services
2009 - Launch of Regulatory Affairs Services
2012 - ISO 9001:2008 Certification
2013 - Launch of Clinical Safety/Medical Monitoring Services
2014 - Office Establishment in Russia and Georgia
2015 - Office Establishment in Switzerland
2016 - Office Establisment in Ukraine: ISO 9001:2015 Re-certification
CLINICAL RESEARCH Strategic Feasibility Studies, Regulatory and Ethics Committee Submissions, Clinical Monitoring, Project Management, Quality and Compliance, Clinical Trial Materials, IMP Management, EDC, Data Management and Biostatistics, Medical Writing, Legal Representation in EU and Switzerland,
REGULATORY AFFAIRS Dossier Development / Medical Writing, Dossier Pre-submission Assessment, CP, DCP, MRP and National Procedures, eCTD and NeeS Compilation, Marketing Authorization Holder Service, Medicinal Product Lifecycle Management, Regulatory Affairs Support in Europe and CIS, Medical Devices and IVD Devices
PHARMACOVIGILANCE Clinical Safety, Medical Monitoring, Pharmacovigilance System including EU-QPPV, EudraVigilance (including XEVMPD) Support, Pharmacovigilance Database, Materiovigilance, Local Pharmacovigilance Representation, Medical Information.