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To summarize my services that can be provided, I am an international regulatory consultant with global expertise in pharmaceuticals - Rx and OTC, drug products and active pharmaceutical ingredients (APIs) - nutritional supplements and medical devices and diagnostic products.
I have extensive experience in the areas of pharmaceutical manufacturing operations, quality systems and risk management, compliance and regulatory affairs - for APIs and dosage forms. I am very well versed in conducting domestic and foreign plant audits for CGMP compliance and integrity, supply chain management and control and also quality systems evaluation, as well as in preparing and filing for approval of Drug Master Files and dosage form product registrations in hard copy or electronic format (eCTD). Along with these activities, I am experienced in preparing for and satisfying U.S. FDA regulatory inspections for facilities and documentation. I am especially experienced in working with people and training them in these activities. My global expertise has been accomplished in companies that I have worked for and with - and in serving on various committees with regulatory agencies, including the U.S. FDA. Further, I am experienced in working intensively with foreign companies to register products in the U.S. - such as companies from China, India, Europe and Mexico. Other services that I provide include due diligence and expert witness activities.
In my past experience, I worked for an Indian pharmaceutical manufacturer (of Active Pharmaceutical Ingredients and Drug Products), with corporate headquarters in Mumbai, for five years. I was their U.S. based person to train people to develop Drug Master Files and ANDAs toward product registrations, instruct people in preparation for successful regulatory inspections including the U.S. FDA and create and implement programs to upgrade the factory and quality systems. Also, I functioned to establish joint ventures for marketing partners. In this manner, we established superior credibility with the U.S. FDA and obtained numerous product registrations without obstacles and, in some cases, with inspection waivers. Also, I established a personal relationship with the Indian regulators.
Some recent formal speaking engagements include being a speaker and moderator at an IPA/PDA seminar in Mumbai, India in January 1998, on validation. Also, I presented at the annual meeting of the Indian Pharmaceutical Association in January 2000 in Hyderabad, India, on validation. In March 2003, I spoke in Hangzhou, China, on preparation of DMFs. In 2004, I presented two day training seminars on the U.S. FDA CGMP regulations and guidances to 160 people of the Chinese sFDA and API and dosage form manufacturers in Worli, China in April and an additional training session to more than 150 people of the Chinese sFDA and pharmaceutical manufacturers in Beijing in September. In September 2009, I presented two-two days' training to people of the Chinese sFDA on U.S. and EU plant inspection requirements and procedures and trends in CGMP requirements and regulations - one session in Yantai, China and the other session in Changzhou. I was a moderator in a PQRI-FDA workshop session in December 2010 in Bethesda, Maryland, on process drift in the manufacture of APIs. Also, I have worked for one year with an API manufacturer in Tianjin, China and helped them to pass a U.S. FDA inspection very favorably, after they received four Warning Letters from the U.S. FDA following four unsuccessful inspections over a six year period.
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