Our expertise in GLP/GMP compliance comes from many years of hands-on experience in pharmaceutical R&D ranging from early development to commercialization. We can help our clients ensure that their documentation and quality systems are in compliance so that their development programs are not hindered by compliance issues.

Specifically, we provide:

♦ Protocol writing for method validation, method transfer, and stability studies
♦ Quality audits for vendor qualification, PAI preparation, and general GLP/GMP compliance
♦ Quality system assessment and SOP writing