TSI Life Sciences Brochure

Pharmaceutical companies, medical device manufacturers, biotech companies, healthcare facilities and other regulated organizations are subject to a variety of laws and regulations regarding the production, storage and testing of their products. For example, sterile drugs produced by aseptic processing are subject to FDA Aseptic Guidelines and EU GMP Annex 1, and are classified using ISO 14644-1 standards. Strict regulations help ensure safety and consistency for end consumers.