The European Commission, EMA and the European medicines regulatory network has updated the activities to ensure the availability of medicines during COVID-19 pandemic. The movement restrictions caused by COVID-19 pandemic may have prevented the conduct of regular on-site GMP or GDP inspections and could therefore result in the expiry of the validity of the periodic GMP or GDP certificates. In order to continue production and distribution activities, the validity of the GMP and GDP certificates issued by the EEA competent authorities will be automatically extended until the end of 2022. The validity of the GMP and GDP certificates was previously extended in spring 2020 until the end of 2021.
Our growth story continues – DRA Consulting to become part of the PharmaLex Group
DRA and PharmaLex are merging to create a centre of pharma and Health Tech expertise with nearly 3,000 experts. The merger will bring synergies for the customers of both companies while helping to accelerate Nordic cooperation in the pharmaceuticalmarket.
Press Release: PharmaLex expands Nordic footprint across key business units with DRA Consulting merger
PharmaLex expands Nordic footprint across key business units with DRA Consulting merger
New drug substances manufacturing site GMP certified thanks to DRA’s expertise
When building up a new drug substances manufacturing site, our client needed consultation on the GMP requirements, and to complement their own resources, a team of GMP and pharmaceutical chemical experts from DRA was set up.