On January 12, 2015, the FDA Center for Drug Evaluation and Research (CDER) launched the Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. The purpose of the OPQ is to Continue reading
Happy Holidays to our clients, friends, and family – wishing you a safe and enjoyable winter season.
As we welcome in the holidays we say goodbye to a phenomenal year that saw Regxia go through several pivotal changes that have allowed us to grow and strengthen our commitment to serve our clients.
This past year, we Continue reading
The revised procedural guidance European Medicines Agency Post-Authorisation Procedural Advice for Users of the Centralised Procedure is intended “to ensure that Continue reading
The FDA has released a guidance for industry titled ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers. This guidance provides answers to questions from the Continue reading
Thirteen prequalified companies have accepted participation in the FDA Secure Supply Chain Pilot Program to enhance the security of imported drugs. As announced in August 2013 Continue reading
Canadian Government Introduces New Law to Protect Patients – 2013 Throne Speech Commitments on Mandatory Adverse Drug Reaction Reporting, Recalls and Accurate Labels Continue reading
Health Canada has implemented a pilot project concerning the implementation of Good Manufacturing Practices (GMP) requirements for active pharmaceutical ingredients (API).
This pilot affects Continue reading
On October 11, 2013 the Government of Canada outlined actions it will take to communicate more effectively on recall-related risks to the public. This announcement comes after an independent report into a high profile recall earlier this year. Although Health Canada Continue reading
September 19, 2013. Regxia’s clients speak:
“Your team is extremely reliable and consistently provides valuable expertise and high quality work in a cost-effective manner. Continue reading
In an effort to better secure the pharmaceutical supply chain within the United States following years of highly publicized counterfeit cases, the FDA has announced the launch of the Secure Supply Chain Pilot Program (SSCPP). The basis of the program would allow Continue reading