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FDA Regulatory

  • 501(k) Application – Assistance in preparation of a pre-submission and in preparation and filing of the 501(k) including clinical, bio compatibility, and other testing.
  • QA Manual & GMP – assistance in preparation of a Quality Control Manual as well as Good Manufacturing Practices requirements as per FDA Regulations.
  • Audit Preparation – Assistance in preparation for an FDA Audit with Internal Audit Procedures.

Expert Witness

  • Expert witness service in Medical Product Liability Cases. Full service as an expert witness on product failures and analysis in legal cases. Depositions as well as trial appearances

Intellectual Property

  • Provisional Patent Application - Assistance in preparation and filing of a Provisional Patent Application with the United States Patent and Trademark Office.
  • Patent Application – Assistance in preparations and filing of Patent Application as well as prosecution until patent issuance.
  • Trademarks – Assistance in preparation and filing of trademarks.

Contract Negotiation

  • Assistance in contract negotiations including licensing and royalty agreements with industry and universities to achieve the best results for our clients.
(818) 701-7180
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