RECENT POSTS
Happy New Year
HAPPY NEW YEAR … NOW IT’S TIME FOR YOUR “PRODUCT QUALITY REVIEW” The “Annual Product Quality Review” is an essential element of the Quality system.
The new Federal Act on Data Protection enters into force in September 2023 – How well are you prepared?
The new Federal Act on Data Protection enters into force in September 2023 – How well are you prepared? Author: Dr. Astrid Tran-Glück, Certified Data
Why do you need a Swiss Authorized Representative(CH-REP)?
Why do you need a Swiss Authorized Representative (CH-REP)? Author: Pragash Vijay, Regulatory Affairs Specialist A Swiss Authorized Representative (CH-REP) is now mandatory after the
Abrogation of the Mutual Recognition Agreement (MRA) for Medical Device – What are the new challenges for companies doing business in medical device area?
Abrogation of the Mutual Recognition Agreement (MRA) for Medical Device – What are the new challenges for companies doing business in medical device area? Author:
How To Survive FDA Inspection (003)
How To Survive FDA Inspection (003) FDA versus EU, what we should know Preparation: What could help us Some advices US FDA versus EU EU
Revision of the Swiss Data Protection Act on September 25, 2020 – What is new?
Revision of the Swiss Data Protection Act on September 25, 2020 – What is new? Author: Dr. Astrid Tran-Glück, Certified Data Protection Officer The Swiss
PMS as leader consulting company for biotech start-ups
PMS as leader consulting company for biotech start-ups PMS Process Management System has supported start-up in (bio)pharmaceutical sector for many years. But, for the first
Compliance vs. Quality
Compliance vs. Quality Author: Stéphane Gumy, General Manager PM Systems S.a.r.l For more than 20 year now, I work for the pharma and medical device
Joined Training Platform
Joined Training Platform Process Management System (PMS) and the Biofactory Competence Center SA (BCC) are pleased to announce a new collaboration for the delivery of
GMP aspects of Contract Manufacturing
GMP aspects of Contract Manufacturing Author: Dr. Maurice Wermeille, Sr. Consultant at PMS Process Management System Ltd. 1. Introduction Contract manufacturing is used in situations