Our services support preparation of regulatory submissions (IND, IMPD, NDA, ROW) including drafting and review of CMC sections.

Consulting analytical services for the pharmaceutical industry in combination with laboratory services.

Comprehensive one stop solution for clients' analytical development needs.

Efficient approach to stage appropriate CMC and quality control strategies while meeting all regulatory requirements.

All phases of global new drug development for small molecules from early pre-IND stage through clinical development to commercialization readiness.

Our expert's focus will provide early detection of trends and issues in your project.  Our services improve decision making by providing analytical expertise and phase appropriate strategic and tactical recommendations.

Our experienced analytical experts substantially improve oversight of the analytical activities at CMOs by being actively engaged in your development process.

Analytical Advisory Services