If you are evaluating your regulatory strategy for a new product, look to PMI. Through our competencies and alliances in regulatory affairs, we can facilitate an assessment of the regulatory requirements for market entry and prepare reports or presentations for use in your strategic and operational business planning. When your business objectives require data to support regulatory submission or marketing claims, we have the experienced resources to help you determine the most appropriate data for collection We can facilitate the preparation of your regulatory submissions or provide tactical guidelines for you to develop your own.

Our Medical Product Registration services include:

  • Establishment Listings
  • IDE Progress Reports
  • Investigational Device Exemptions (IDEs)
  • Physician IDEs and INDs
  • Pre-market Applications (PMA)
  • Pre-market Approval Notifications 510(k)
  • Product Listings

 

 

 
   ABOUT PMI   |   SERVICES   |   TECHNOLOGY   |   INVESTIGATORS   |   CAREERS   |   CONTACT US   |   SITE MAP   |   PRIVACY POLICY / DISCLAIMER 1998 - . All Rights Reserved.
   CLINICAL RESEARCH ORGANIZATION (CRO)