Services

Formulation, analytical and manufacturing expertise
Regulatory CMC expertise and POM to P switching
Intellectual Property (IP) development and management
External resources procurement and management
Hands-on and/or remote formulation support
Management of in-house (or external) formulation development activities:
Formulation design, drug delivery technology assessment and selection
Compilation of formulation and process documentation
Preparation of full regulatory CMC packages for CTA and IND
Preparation of Quality Overall Summaries and Quality Overviews