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Aivaras Aliukonis

Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion.

Biomapas appoints Head of Global Regulatory Affairs

By | news1

May 2020 – Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion. As a functional and full outsourcing solution provider, with offices in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine, Poland and Kazakhstan, Biomapas continues to expand its international team and further increases capabilities for client-oriented solutions.

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Karolina Mickutė, MPharm, Regulatory Documents Translation Process - How to Ensure Consistency and Correctness

Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

By | news1

Mistranslation of regulatory documents such as common technical documents dossiers, a summary of product characteristics, labelling, product information leaflets and instructions for use, could have a negative impact for the company and most importantly could lead to serious consequences to a patient’s health. In 2007, as a result of inaccurate translation, 47 patients had badly implanted knee prostheses. An outer package labelled in English included different information.

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Biomapas Opens a New Office in Kazakhstan

By | news1

April 2020 – Biomapas announced the opening of a new office in Central Asia. The new location in Kazakhstan strengthens Biomapas presence in the CIS region and further improves flexible and reliable clinical, regulatory and pharmacovigilance service delivery to the global life science industry in emerging markets. As a functional and full outsourcing solution provider, with a new office in Almaty, Biomapas continues to expand its international team and ensures the efficiency of services in 65 countries across 5 continents.

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MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

By | news1

Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers (HCP), pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder (MAH). During the National semi-annual conference „Pharmaceutical News“ in Lithuania, State Medicines Control Agency representative delivered a presentation on the statistics of suspected adverse drug reaction (ADR) reporting in Lithuania.

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Sebastien Duval joins Biomapas as Chief Business Officer to lead the business development department and extend Biomapas continued growth in the global life science industry.

Biomapas appoints Chief Business Officer

By | news1

March 2020 – Sebastien Duval joins Biomapas as Chief Business Officer to lead the business development department and extend Biomapas continued growth in the global life science industry. Sebastien Duval brings over 20 years of experience in the life science industry, previously acting as VP Sales Account Management at IQVIA, and further back in his career working as VP Business Development at Synteract, Executive Director, Global Head of Clinical Phase II-IV Business Development at QPS and as VP European Business Development at Premier Research.

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Oleg Kungurtsev, MD, Manager Clinical Operations, Country Manager Ukraine at Biomapas

Running a Clinical Trial in Ukraine

By | news1

Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.

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Martijn van de Leur as Head of Global Pharmacovigilance.

Biomapas appoints Head of Global Pharmacovigilance

By | news1

March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.

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Poland 2020

Biomapas strengthens its footprint in Poland in the run-up to its further growth in Central Europe

By | news1

February 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry Biomapas announced strategic growth in Warsaw. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and now in Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, with a new office in Central Europe Biomapas will strengthen its international team and geographical coverage of its services.

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Regina Auškalnienė, Head of Clinical Operations at Biomapas

Regina Auskalniene will lead Lithuanian Good Clinical Practice and Regulatory Affairs Association

By | news1

Regina Auskalniene, Head of Clinical Operations at Biomapas, was elected to lead Lithuanian Good Clinical Practice and Regulatory Affairs Association. The association unites middle size and global CROs in the Baltic countries and is focusing on creating the most efficient environment in Europe to deliver clinical trials. „Everyone in our association agrees that we can run much more clinical trials in the Baltic states, thus creating an attractive place for clinical research in the future,” said Regina Auskalniene.

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Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

By | news1

The trend of outsourcing continues to grow in the life science industry. Global regulatory affairs outsourcing market was valued at US $5.7 billion in 2018, and is expected to witness a compound annual growth rate of 11.9% over the period to 2026. Regulatory affairs outsourcing may vary in extent (from stand-alone service to full-scope solution), length (project based or long-term partnership with selected vendor), model (insourcing a dedicated expert for specific project or functional service provision), etc.

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