Pharmaceuticals and Nutraceutical Dosage Form Consultant

Expertise

• 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.

Experience

Undisclosed Company

• 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.

Previous Employment

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

Patents

• 2 formulation patents
• 1 patent pending-Immunity product for AIDS Virus

Education

• MBA Pharmaceutical Business Administration, Fairleigh Dickinson University, NJ
• M.S. Pharmacy, Rutgers College of Pharmacy, NJ
• B.S. Pharmacy, India