Services we Provide

Greenleaf’s comprehensive services and wealth of experience ensure that clients can count on expert guidance as they navigate complex regulatory challenges. Greenleaf’s experts lead teams specializing in product quality, manufacturing and compliance; medical devices and combination products; and drug and biological products.

The firm’s targeted regulatory services include:

  • Strategic and technical guidance for medical product development and regulatory review
  • Product lifecycle management
  • Product quality, manufacturing and compliance
  • Submissions: 510(k), PMA, 513(g) requests, HUD, HDE and IDEs
  • FDA meeting preparation and communication
  • Advisory services
  • Medical product labeling and promotion
  • Regulatory policy guidance
  • Strategic planning and communications

To learn more about Greenleaf’s comprehensive services, click here.