POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products
POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products
POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products
Are you really moving towards a GLocal Regulatory approach? by: Concetta Aulicino […]
How the Regulatory Affairs Landscape can change in the post Covid-19 Era: […]
PQE Group is proud to announce its new partnership with Taman Associates, […]
Impact of possible removal of the Titanium dioxide from human medicines formulations […]
Technology Transfer has always been a hot topic and can be even more challenging for complex processes/products like biotechnological ones.
In this Covid-19 pandemic era, different companies are facing technology transfer processes as a mandatory way to boost their covid vaccines production and follow patients’ need, shifting a series of contract manufacturers across the world that must inherit their technology and achieve compliance in a really short timing to meet the production goals.
The European Council and Parliament officially adopted an amendment to Regulation 2017/745, modifying the most of application dates to May 2021.
The second draft of GMP Annex 1 has been recently released and the issue date for the new revision is finally approaching. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended.
PQE Group is delighted to announce its new partnership with Rephine, a UK based multinational audit and consultancy company
Published today in the Official Bulletin of the State, the legislative decree […]