From FDA and FTC regulatory consulting to quality assurance and quality control, Botannis is proud to offer a comprehensive range of capabilities to ensure your product meets industry requirements. With decades of experience, we are proud to stand alone in our ability to prevent and rapidly resolve many of the compliance issues a product could face on the road to commercial distribution.
FDA and FTC regulatory evaluation of the following:
- • Dietary Supplement, Drug and Cosmetic label review
- • Stability protocols
- • Cleaning, Method and Process Validation
- • Formulation and Product development (Quality By Design)
- • Promotional and Marketing material claims
- • Evaluation and design of Standard Operating Procedures (SOPs) to meet current Good Manufacturing Practices (cGMPs)