Regulatory Strategy

PharmaCambridge understands the importance of a sound regulatory strategy to ensure products gain approval and reach the market as quickly as possible. We have extensive experience of presenting to and negotiating with regulatory bodies in the USA, Europe, India, Singapore and Japan.

Our services include:

• Pre-approval strategy
• Submission management (INDs, NDAs, CTAs)
• Arranging & conducting meetings in person with key regulatory bodies
• Post-approval compliance strategy and management