Abu Huq

Background

About Abu Huq

Highly qualified technical leader with strong background in developing both conventional and controlled-release pharmaceutical dosage forms including sterile injectables, sterile ophthalmics, sterile implants, tablets, capsules, soft gels, powder granules, ointments, oral suspensions/solutions and transdermal products. Conversant with all stages of product development (API selection, pre-formulation, formulation development, process development, scale-up, process validation, quality control, regulatory filings and commercialization) and all aspects of technology transfers (protocol preparation, batch record review, summary report preparation, site inspection preparation). Extensive experience in preparing CMC dossiers, presenting reports to domestic and international regulatory agencies, managing FDA Pre-Approval Inspections, and working with outside companies both for product development/manufacture and for developing stability-indicating analytical methods. Expert in product life-cycle management.