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Structure of the Common Technical Document (CTD)- M4 Guideline
What is the Common Technical Document (CTD)? The Common Technical Document (CTD) format or dossier was designed by the ICH and was agreed upon as a common format between three major regulatory regions, i.e. European Union (EU), USA, and Japan for submission of...
Top 2 FDA Citations to Avoid
The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals and how to avoid or prevent them. In the United States of America, pharmaceutical drugs and medical devices are controlled according to The...
Innovations in Validation: Advancing Cell and Gene Therapies
With the ever-changing mechanics of innovation in the manufacturing environment, work from home and federal regulation validation strategies need to evolve to accommodate the new space. This white paper provides the background, rationale, and strategy for innovating...
Use of Multi-Disciplinary Validation Teams for GXP Projects White Paper
Maximize efficiency and effectiveness in your validation projects by utilizing multi-disciplinary teams. The term "Validation," as used in this white paper, will be taken to mean either or both activities of Qualifying systems and facilities as fit-for-purpose...
Nonstop Growth in 52 Countries Produces Multiple Careers within PSC Biotech®
PSC Biotech® has offices across North America, Europe, and Asia. PSC operates in 52 countries globally and has served thousands of clients to date. Since PSC Biotech® is a recognized name with over 25 years of experience, we have many jobs ready and upcoming on new...
Quality Risk Management for Commissioning and Qualification
Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and medical device industries define a detailed and science-based process for the specification,...