Some Major Accomplishments
• carrying out all aspects of new product definition and development, including all outsourcing arrangements, for a series of new biologic and drug products
• coordinating, in China, cGMP compliant construction and outfitting of a facility for production of pharmaceuticals, including all aspects of qualification and validation, and complete documentation
• creating the plan for the successful reorganization of the largest Public Health Service Laboratory in the United States
• successfully leading, as head of New Products and Quality Units, a cutting-edge biotech firm from early R&D to several multi-million dollar development and production contracts
• acting as US agent for a major German company, with over a billion dollars in annual sales worldwide, handling all FDA interactions across the several product lines
• leading a cutting-edge US biotech firm successfully through the initial pre-IND meeting with the FDA, resulting in a clear action plan and secondary funding
• successfully preparing, submitting and defending regulatory applications to CBER, CDER, and CDRH at the FDA8
• obtaining approval for a drug for a US company, first dealing with an FDA recall and a Warning Letter, and, after redoing the company’s GMP documentation and Quality Systems, accumulating the clinical trial information, and preparing, submitting and defending the NDA for the product
• obtaining licensure for a Swedish monoclonal antibody producer after leading the introduction of GMP and the creation of all support documentation
• obtaining licensure for a German vaccine manufacturer after performing the needed audits and reviews, helping in the documentation of the operations, and creating the needed submissions
• coordinating for a US importer and distributor all aspects of approval of several devices imported from Asia
• helping a several major manufacturers deal with all aspects of resolving Warning Letters
• developing, for a technology-based company, strategy, patents and first products
• creating and conducting FDA approved clinical trials for manufacturers of biologicals, drugs, and devices
• successfully training companies world-wide to understand and to operate in compliance with GMP and QSR
• leading, for companies in the US, Europe, Israel, Japan, and China all interactions with the FDA related to planning of new facilities and to reconstruction of current  facilities
• developing complete documentation package necessary to support operations of a new biological manufacturer
• raising the level of quality systems and compliance for a major French diagnostic company, leading to introduction of products into the US market
• providing to clients, through pre-inspection and review, the training needed to successfully pass FDA and other regulatory inspections