The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs, pharmacovigilance.
Associate Director Business Development Egle Pavyde, shares some thoughts about region peculiarities, recent legislation changes and Biomapas experience providing RA and PV services in CIS.
Biomapas currently covers 64 countries across Europe, CIS and MENA regions. Being able to provide clinical trial, regulatory affairs, medical writing and vigilance solutions to all of these countries requires us to have a large repertoire of native speakers on staff.
Since providing top quality work to our customers has always been of paramount importance for Biomapas, we needed a way to ensure document accuracy, and therefore decided to look at proofreading software to help us maintain quality.
Compliance with high quality standards is a non-negotiable performance parameter in Pharmaceutical and Medical Device industries. During 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485 implementation into BIOMAPAS Quality Management System was initiated. We discussed the influence of current changes to the whole company and its quality management with Egidija Pauriene, MD, Quality Assurance Director.
The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (EU). This means that the United Kingdom will become a ‘third country’ from 30 March 2019.
According to Directive 2001/83/EC the reference member state (RMS) must be a member of the EU. As a result the RMS role in Mutual Recognition and Decentralised Procedures (MRP/DCP) must be transferred to an EU country.
The Association of International Clinical Research Organizations (AICROS) is a network of small to mid-size CROs, which provide clinical research services to the pharmaceutical, biotech and medtech industries. Biomapas joined AICROS in 2014 and since then has been an active member of the association. On the 20-22 February, Biomapas’ CEO Audrius Sveikata participated in the AICROS Annual meeting, which took place in Tel Aviv, Israel. Audrius shared his insights about the meeting and the future perspectives of the association.
Biomapas a annoncé récemment avoir reçu de la part du Ministère de l’enseignement supérieur et de la recherche l’accréditation Crédit d’Impôt Recherche (CIR) pour une période de trois ans.
Biomapas has recently announced that it has received Research Tax Credit (Crédit d’Impôt Recherche; CIR) accreditation for a three-year period from the French Ministry of Higher Education and Research.
On 11th June 2017, Biomapas team has participated in Citadele Kaunas Marathon, which took place in Kaunas old town. Watch the video with exciting moments from the run!