Electronic submissions have become the preferred method for submitting applications for post-authorization approval among the three regions that are party to the ICH. In February 2004, ICH M2 Expert Working Group has released the eCTD Continue reading
The European Medicines Agency’s (EMA) initiative to share Continue reading
The EMA has released a new finalized guideline called Similar Biological Medicinal Products which introduces the main concept of the “possibility for drug product developers to use comparators authorized outside the European Economic Area (EEA)” during clinical development of biosimilars.
The new guidance 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 International Generic Drug Regulators Pilot (IGDRP) was created in 2012 to promote collaboration and convergence in generic drug regulatory programs in order to Continue reading
On April 30, 2014 the EMA released the Guideline on non-clinical local tolerance testing of medicinal products for comment and is intended to replace the Continue reading
Regxia Inc. is pleased to advertise that they will be exhibiting with the Drug Information Association (DIA) at their 50th Annual Meeting in San Diego from June 15-19. Regxia will be occupying Booth 1944 and 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
On April 3, 2014 at 12:00 EST Regxia Inc. launched its first corporate rebranding, encompassing a refinement of the company’s logo and a re-launching of the corporate websites. Regxia’s Vice President and co-founder Lori Steinhoff – de Munnik, RAC sees “Regxia Inc.’s rebranding and website re-launch as Continue reading