LIFE SCIENCES: PHARMA + MEDICAL DEVICES

The life sciences industries are highly-regulated. Having managed Class I-III product portfolios for world-class manufacturers, I can help you focus on the identification and management of legal risks associated with the sale and distribution of your company’s products, including the following:

 

  • Food and Drug Administration (FDA) requirements

  • Classification of product(s)

  • Pre-market review

  • Manufacturing and production of product(s)

  • Supply chain

  • Quality standards

  • Inspections and audits

  • Recalls

  • Product labeling

  • Package design

  • Advertising and promotion, including websites and social media

  • Medical, Legal, and Regulatory review, including Promotional Review Committee(s)(PRCs)

  • Collaboration(s) with top science and engineering experts

 

If you need guidance, contact us here.

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