Personal Information
Organization / Workplace
Dallas/Fort Worth Area United States
Occupation
Vice President Regulatory Affairs at OTC Manufacturer
Industry
Medical / Health Care / Pharmaceuticals
About
Started my career as a clinical pharmacist. As time passed the monotonous prescription dispensing did not fit my style. For a change i started formulations on side launched successfully 7 OTC products, 2 new drug delivery system and pleasure to own 3 process patent. Later developed 4 cosmetic formulations and sold them to fortune 500 companies.
During my formulation designing experience I got lucky to have hands on quality and regulatory affairs by facing several audits namely the two main FDA and Health Canada.
Till date, I have successfully acquired hands on knowledge for ISO certification, 510k submissions and clearance, SPL submissions to fda, Drug Master file submissions, Health ...
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