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
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