Recent Client Services

• Guided the development of an optimized development strategy minimizing experimentation requirements for a Phase II product and positioned the asset for acquisition by a major global Pharma company.
• Provided a successful technical defense of a formulation patent for a virtual Pharma company.
• Optimized key pharmaceutical development procedures for a large Pharma company, accelerating operational processes and enhancing staff effectiveness.
• Authored regulatory modules for clients with Phase I, Phase II and Phase III INDs.
• Reviewed CTM manufacturing and packaging batch records for a small Biotech company.
• Provided technical expertise to resolve manufacturing issues for a solid dosage form.
• Authored a white paper on the value of a client’s technology platform to support communications with potential investors.
• Solved a content uniformity and blend segregation problem for an NCE tablet formulation.
• Provided formulation, process optimization and scale-up expertise for a new NCE entering phase III; decreasing development time 6 months and saving $300,000 in CRO costs.
• Authored key foundational documents supporting the Quality Operations program for a large Pharma company.
• Provided guidance and technical review of a Drug Master File for a European Pharma company.
• Performed a GAP Analysis for a client’s NDA modules and developed a successful regulatory submission strategy.
• Provided guidance and recommendations to a Pre-Approval Inspection Readiness team, leading to a successful PAI, with no issued 483 observations.