International Pharmaceutical Consultants, Inc.:

Reviewed all of the clinical Study Summaries, developed the algorithm for the analysis of the clinical laboratory values, wrote the Integrated Summary of Safety and the Integrated Summary of Efficacy for a Quinolone Anti-Infective NDA.

Reviewed products for licensing and development, due diligence review of corporate activities prior to public offering.

Formulated development plans, written work practices and SOPs, and provided advice about clinical programs.

Written protocols (Phases I, II, and III), Study Summaries, Investigator's Brochures, and the clinical sections of INDs (e.g. a long acting insulin and a thromboxane A2 inhibitor for cardiovascular and pulmonary usage).

Evaluated thousands of Case Report Forms for safety and clinical efficacy.

Planned and revised clinical safety sections of INDs and NDAs.

Safety and medical monitor for active INDs.

Presented a Phase II protocol and development plan for an a1 antagonist to the FDA, and then 2 years later, presented the clinical results at an End-of-Phase II meeting, and 3 years later, presented the results at a Pre-NDA meeting, NDA submitted April 15, 1996, approved April 15, 1997.

Written Expert Clinical Reports for European registration.

Written sections of NDAs (ISS, ISE, Application Summaries, Study Summaries) and European registration submissions (Study Summaries).