Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?
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...
Changing regulatory environment: eCTD submissions to become obligatory as of 2018
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...
Tuberculosis Medicines Clinical Development in Eastern Europe and CIS
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...
