Chemical Consultants Network Listing for Edwin L. Crow

Expertise in the following areas:

1. Technology and product development, commercialization and manufacturing.
2. Technology transfer from R&D into manufacturing or across other organizational interfaces.
3. Strategic and tactical planning and implementation associated with new products.
4. CMC sections for IND's, NDA's, DMF's, and ANDA's reviewed and written.
5. Expert Reports for foreign applications written and reviewed.
6. FDA pre-approval inspection preparation.
7. Management of contract manufacturing firms, including selection and ongoing relationships. Evaluations conducted in the following areas:
   • Technical staff
   • Regulatory
   • Quality
   • Environmental
   • Equipment
   • Infrastructure
8. Cleaning and process validation guidance, including protocol design and critique. Equipment IQ/OQ protocol design and critique.
9. cGMP assesments made for laboratories, pharmaceutical and API development and manufacturing activities. Necessary cGMP upgrading recommended.
10. Engineering evaluations of processes, utilities and facilities.
11. Packaging solutions provided for many applications.
12. Covers both the bulk pharmaceutical chemical and final dose form.

Dr. Crow is the principal consultant at YATOKA; a consulting company specializing in the pharmaceutical and fine chemical industries. His background includes 28 years with DuPont, DuPont Pharmaceuticals and DuPont Merck in a variety of positions in R&D and Manufacturing.

In his last assignment at DuPont Merck he was Sr. Director of technology and Engineering responsible for introduction of new products (both final dose form and API). This responsibility included technology, business planning and project management. Other responsibilities included technical assistance for final dose form at three plants, Packaging engineering, Chemical Manufacturing and Central Facilities Engineering groups.

He was also chairman of PhRMA's Active Pharmaceutical Ingredient Committee and has chaired meetings with PhRMA and DIA addressing API issues. He has also spoken at the Penn State University Center for Validation and at other professional and individual company meetings.

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This page was last updated on October 10, 1998 by the CCN webpage development team

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