ISO 9000:2015 & ISO 9001:2015
ISO 9000:2015 and ISO 9001:2015 are pivotal standards in quality management systems (QMS), setting the benchmark for excellence across…
ICH Q8 – Quality by Design
The ICH Q8 guideline focuses on pharmaceutical development. It aims to establish a systematic approach to designing, developing, and manufacturing pharmaceutical products. This guideline is…
ICH Guidelines Decoded
The International Council for Harmonisation (ICH) is an organization that brings together regulatory authorities and the pharmaceutical industry from different regions…
Regulatory Affairs | Vaccine Registration
This project is ongoing, PSC Biotech® is helping our client located in St. Louis with registration of their animal product (vaccine) in 3 countries, UK, Australia and New Zealand.
Regulatory Affairs | Strategy Support Projects
PSC® continues to support the Global Regulatory Affairs division for a large biopharmaceutical company, focused on plasma-derived therapies for rare and complex diseases. This company’s headquarters is in Cambridge, MA, but we support locations in the Greater Atlanta region and Greater Los Angeles region.
