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FDA Consultant Alan Schwartz

mdi Consultants, Inc.

Alan Schwartz

Executive VP

55 Northern Blvd.

Great Neck NY 11021
USA

phone: 516-482-9001

fax: 516-482-0186

Email Website
mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:
  • Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients
  • Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment
  • Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

    • Related areas of expertise

    Biotechnology FDA Regulation (Food Drug Administration) Food Safety Food Technology Healthcare (General) Medical Equipment Products Labeling / Warnings
    Business (General) Food & Beverage Food Safety - Hazard Analysis & Critical Control Points (HACCP) Government Regulation - Codes Standards Medical Devices Pharmaceutical Medicine Quality Assurance / Management

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