Biomapas

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http://biomapas.eu/
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
Founded 2001
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.

History

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

Services

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.


References

1.http://biomapas.eu/

2. https://www.linkedin.com/company-beta/2675672/

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