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Pharmaceutical Product Development

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

© 2018 Asterx Pharma Consulting LLC
915 Klosterman Road East
Tarpon Springs, FL 34689 USA