PHARMA + MEDICAL DEVICES/EQUIPMENT

The pharma and medical device/equipment industries are highly-regulated by the government. 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 distribution, marketing, and sale 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.

The principal office for Orton Heath Law Firm is based in Austin, Texas. Please call or use the contact us form to schedule a meeting.

CONTACT US

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Orton Heath Law Firm PLLC

1101 West 34th Street, # 484

Austin, Texas 78705

512.537.2187

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Lorrie is the founding attorney of Orton Heath Law Firm, based in Austin, Texas.  She routinely consults with individual and corporate clients across various industry segments...