Services

Our experts are ready to support you through every step of the pharmaceutical product development process, leveraging our scientific, clinical and regulatory expertise to help you realize your product.

-Formulation Development

-Product & Process Controls / CMC

-Analytical Methods Development, Verification, Validation

-Process Development & Optimization

-Process Scale-up

-Process Validation

-IQ/OQ/PQ

-IND Strategies, Submissions, and Updates

-Orphan Drug & Breakthrough Therapy Designation

-505(b)(2) strategies

-Investigators Brochure

-Clinical supplies manufacturing & packaging

-Pharmacokinetic Study Design

-Preclinical Study Design

-Act as your US FDA regulatory point of contact