by Nick | May 8, 2020 | Regulatory Affairs
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...
by Nick | Jan 31, 2020 | Regulatory Affairs
The trend of outsourcing continues to grow in the life science industry. In particular, the 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...
by Nick | Aug 2, 2019 | Regulatory Affairs
In the process of marketing authorization, competent authorities classify medicinal products as the subject or not-subject to medical prescription. However, the classification of medicinal products can be reevaluated and changed via a regulated procedure. When...
by Nick | Jul 2, 2019 | Regulatory Affairs
July 2019 – Ramune Rukiene joined Biomapas as Director Regulatory Affairs to further strengthen continued growth and geographic extension of Biomapas. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, and Ukraine, Biomapas provides services in...
by Nick | Jun 7, 2019 | Regulatory Affairs
Current Background in the EU The IDMP (Identification of Medicinal Products) is a general term by which the 5 ISO data standards are referenced: ISO 11615 (regulated medicinal product information), ISO 11616 (regulated pharmaceutical product information), ISO 11238...
by Nick | May 7, 2019 | Regulatory Affairs
Falsified Medicines Directive (FMD) 2011/62/EU which aims to increase the security of manufacturing and delivery of medicines across Europe as well as protect patients and prevent falsified medicines from entering the supply chain has come in force Feb 9th, 2019. With...
