- 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 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
- 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.
- Assistance in contract negotiations including licensing and royalty agreements with industry and universities to achieve the best results for our clients.