by Nick | Mar 8, 2019 | Clinical Research, Pharmacovigilance, Regulatory Affairs
On 29th March 2017 United Kingdom (UK) submitted 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 30th March 2019. Even...
by Nick | Oct 11, 2018 | Regulatory Affairs
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....
by Nick | Oct 11, 2018 | Regulatory Affairs
Compliance with high-quality standards is a non-negotiable performance parameter in the Pharmaceutical and Medical Device industries. In 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485...
by Nick | Sep 10, 2018 | Regulatory Affairs
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...
