CIS and Eurasian Economic Union: high Pharma industry interest and new legislation
October 3, 2017
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: Improving the Document Review Process
August 2, 2017
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. (more…)
Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?
June 5, 2017
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. (more…)
Changing regulatory environment: eCTD submissions to become obligatory as of 2018
April 26, 2017
A new challenge is about to be faced by the Marketing Authorization Holders of medicinal products. Since online tools are becoming a bigger part of our daily lives, the competent authorities are also moving forward step by step. As of 1st January 2018, the European Medicines Agency will require that all regulatory submissions for medicinal products authorized via Decentralized or Mutual Recognition Procedure will be provided in eCTD format.
Tuberculosis Medicines Clinical Development in Eastern Europe and CIS
March 24, 2017
World Tuberculosis Day is commemorated every year on 24th March to raise awareness of tuberculosis, which is still causing death of nearly 1.5 million people each year, mostly in developing countries. It marks the day in 1882, when Dr. Robert Koch announced that he had discovered the cause of tuberculosis, the TB bacillus. In comparison to other infectious diseases caused by a single infectious agent, tuberculosis is the second biggest killer worldwide.