Projects

Below are some examples of on-going and completed projects that we have worked on. The list is by no means a complete list but is provided so as to highlight where our skills have added value or helped our Clients meet their corporate objectives.

Analytical and Formulation Development

·  Developed specifications and control strategies for various drug substance and drug products, including oligonucleotides, small molecules, peptide.

·  Provided guidance and oversight on formulation activities for a peptide parenteral products.

·  Developed and validated analytical methods for small molecule and biopolymer actives and formulated pharmaceuticals.

Manufacturing, Outsourcing, and Technology Transfer

·  Performed a vendor screening process and selected a manufacturer for a small molecule drug substance.

·  Oversaw process development and manufacturing activities for multiple clients including oligonucleotide, small molecule, protein , and peptide drug substances and topical, oral, injectable, and sustained release drug products. 

·  Developed and oversaw the execution of a master validation plan for a drug substance manufacturing facility. Plan encompassed facilities, equipment, cleaning, process, and analytical methods.

Regulatory, Quality, Auditing, and Compliance

·  Wrote Module 3 sections of CTDs to support INDs and NDAs for an oligonucleotide topical, a small molecule injectable, and a small molecule oral dosage form.

·  Represented companies as CMC expert at Type C, End of Phase 2, and pre-NDA meetings with the FDA for topical, optical, and parenteral (injectable) products.

·  Audited API and drug product suppliers for compliance with regulatory requirements.

·  Designed and implemented Quality document system for SOPs and other controlled documents.

Strategic

·  Reviewed CMC program for an oral dosage product and prepared supporting documents in preparation of due diligence activities for partnering discussions.

·  Reviewed CMC sections of due diligence packages for a client looking to in-license a new product to ensure that CMC programs were complete and that budget estimates for required activities were on target. 

·  Prepared CMC project plans and budgets to outline manufacturing and clinical supplies required for Venture Capital discussions.