New and generic drug development and regulatory submissions in the US/Canada.

Preparation of pharmacology/toxicology and clinical sections of regulatory documents, such as IND/CTA, NDA, ANDA and labeling.

Preclinical and clinical development of new and generic drugs and formulations, including generic oral and topical drug formulations supported by bioequivalence, vasoconstrictor assay, clinical endpoint bioequivalence studies, in vitro dissolution/release or a customized approach. 

Development of Investigator Brochures, preparation/review of study protocols, filing IND/CTA, preparing responses to deficiency letters/requests for clarification, drug safety reports and meeting and collaborating with FDA/PDD.

FDA product registration via 505(b)(1) and 505(b)(2) NDA’s.

Electronic product licensing with Natural and Non-prescription Health Products Directorate (NNHPD).

Pharmacokinetics/pharmacodynamics, quantitative clinical pharmacology, clinical trial design, bioequivalence, pharmacometrics, and drug absorption analysis.