The recent trend of increasing CGMP violations involving data integrity identified during FDA inspections has created a cause for concern with the agency. This trend is “troubling because 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
A Certificate of a Pharmaceutical Product (CPP) is a certificate used by the Health Products and Food Branch Inspectorate (HPFB Inspectorate) “establishing the status of Continue reading
On April 25, 2014, the EMA released a draft guideline on Process Validation for the Manufacture of Biotechnology-derived Active Substances and Data to be Provided in the Regulatory Submission. This document is intended to provide guidance on 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
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
Health Canada’s Health Products and Food Branch (HPFB) Inspectorate has notified stakeholders that Canada’s Food and Drug Regulations have been amended. The change extends Division 1A – Establishment Licensing and Division 2 – Good Manufacturing Practices (GMP) to active ingredients used in pharmaceutical drugs for human use 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
A new FDA draft guidance has been released in an attempt to clarify the agency’s expectations around generics stability testing.
Primarily, generic drug manufacturers submitting abbreviated new drug applications (ANDAs) are “principally concerned with 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