Regulatory Affairs (RA)

/Regulatory Affairs (RA)

Marketing Authorisation Applications (MAAs) for medicinal products require both expertise and diligence to ensure that the requirements of the European Medicines Agency (EMA) and the national EU competent authorities are met.
It includes development of strategy and planning, and the evaluation and review of documentation to ensure that your regulatory strategy is successfully executed.
When it comes to Marketing Authorisation Applications (MAAs), we have many years of experience in preparing quality, non-clinical and clinical documentation, and submitting applications in eCTD format in the decentralised procedure, the mutual recognition procedure, and national procedures.

Strengthened team of Regulatory Affairs professionals

Extended resources strengthen our team of Regulatory Affairs professionals We are pleased to announce that Sonja Horsted, MSc. Pharm, has joined the Regulatory Affairs team at PharmAdvice on June 1, 2017. Sonja has more than 25 years of [...]

Strengthened team of Regulatory Affairs professionals2018-09-17T10:55:14+00:00

Good practice for documentation of safety variations

How to ensure good practices for documentation of safety variations By Ea Dige Ensuring good practices for documentation and management of safety variations, starts by optimizing the cooperation between your Regulatory Affairs (RA) and Pharmacovigilance (PV) functions. [...]

Good practice for documentation of safety variations2018-09-17T10:54:01+00:00