Our established quality system is based on the requirements of Good Laboratory Practices, current Good Manufacturing Practices, and Quality System Regulation as promulgated by the U.S. Food and Drug Administration 21 CFR Part 58, 21 CFR Parts 210, 211, and 820 respectively, and by European and other international regulatory agencies.
Big Sky Bio Labs operates in compliance with the highest industry standards to ensure the integrity of every project.
Registered and compliant under FDA regulations for drugs and biologics.
We adhere to current Good Laboratory Practices (GLP) to ensure the quality, reliability, and integrity of non-clinical laboratory studies and testing.
We adhere to current Good Manufacturing Practices (GMP) to ensure the consistent quality, safety, and efficacy of products through controlled manufacturing processes.
We follow International Council for Harmonization (ICH) guidelines for pharmaceutical product testing.
