API and Drug Development

We provide experience based support for the entire range of drug development activities from initial formulation through to full production scale-up.

• Identify and select project-appropriate laboratories/sites to conduct development.
• Route evaluation, scale-up, and phase appropriate oversight at process and analytical sites
• Regulatory starting material definition and designation.
• Contract site management for development of synthesis and formulation.
• Quality by Design (QbD) approach where appropriate.
• Stability protocol design and implementation for API and DP. 
• Couple technical development with regulatory requirements for efficiency.