- Formulation process development of pharmaceuticals and nutraceutical dosage form.
- Tablets, capsules, injectables, creams, ointments and controlled release products.
- Regulatory requirements for pharmaceutical and nutraceutical including FDA, DMF, NDA, ANDA, cGMP, SOPs, auditing, labeling.
- Process controls including validations, operations, specifications, equipment selection, and qualifications, IQ/OQ/PQ.
- International liaisons/licensing of pharmaceutical and nutraceutical raw materials, finished products.
- Sales and marketing including setting up broker, distributor, retailer network, news releases, graphic designing.
- Process development and operation of bulk chemicals and ingredients: microcrystalline cellulose, ranitidine, peroxicam, etc.
- Business development, mergers and acquisitions including business planning, forecasts, contacts for M&A, collaborations.
- Founded and successfully managed pharmaceutical equipment distribution company and ingredients manufacturing company for the past 20 years.
- Managed all company operations including product sourcing, financing, quality, and FDA matters.
- Directed the marketing activities. Established dietary supplements powdered drink products from concept to market.
- Established sales over a million dollar in less than a year.
- Directed the development of dosage forms for large and small molecules from discovery to commercialization.
- Managed product development projects for solids, parenterals, liquid and topical drug delivery systems through scale up, clinical supply manufacturing and technology transfer to pharmaceutical industry including liaison with FDA.
- Also responsible for scheduling, budgeting, task assignments, QA audits, and validation of processes.
- Prepared, reviewed, and submitted NDA and ANDAs for various pharmaceutical products such as Amoxil, Gentamycin, Loperamide, Orth Novum%u2019s Modicon, Miconazole, Fulvicin, and Labetalol.
- Established DMF (Drug Master Files) for many Asian and European Pharmaceutical Bulk Active Manufacturing Companies and assisted them for their plant inspection through U.S. FDA.
- Established a fiber product from start up through a multi million dollar product sale for a company.
- Currently established a new venture for manufacturing of unique herbal and nutritional supplements, such as Glucosamine, energy products, and diet aid products for weight loss.
Warner Lambert / Parke Davis, 1979 - 1981
- QA and FDA Liaison Officer & Technology Transfer
Schering Plough Corporation, 1975 - 1979
- Product Development of Injectables & later on Regulatory Affairs. Established
- SOPs for all departments. Reviewing NDA and Manufacturing Protocols.
Ortho Pharmaceutical Corporation - J&J Corp., 1972 - 1975
- Manufacturing of Clinical Supplies (creams and ointments), Compilation of
- NDA / ANDA Submissions
Smith Kline Beecham,1970 - 1972
- Development of Antibiotic Formulation (Amoxil, Ampicillin, Cloxacillin,
- Dicloxicillin, etc.) for all dosages-human & veterinary.
Cadila Laboratories, India, 1962 - 1970
- Plant Manager. Responsible for complete operation, production, R&D
- (all dosage forms), Labor Management.
Hindustan Antibiotics, India, 1960 - 1961
- Penicillin Manufacturing
Honors & Publications
- 2 formulation patents
- 1 patent pending-Immunity product for AIDS Virus
- MBA Pharmaceutical Business Administration, Fairleigh Dickinson University, NJ
- M.S. Pharmacy, Rutgers College of Pharmacy, NJ
- B.S. Pharmacy, India