Our expertise in regulatory compliance comes from many years of hands-on experience in pharmaceutical R&D, ranging from early development to commercialization. We help our clients ensure that their documentation and quality systems are in compliance so that their development programs are not hindered by regulatory issues.
Specifically, we provide the following consulting services:
- Protocol writing for method validation, method transfer and stability studies
- Quality audits for vendor qualification and general regulatory compliance
- Quality system assessment and SOP writing