What We Do

Achieve new or generic product submissions and approval by relying on our regulatory expertise.

Collaboration and strategic planning is key to bringing a product successfully to market. With a full complement of regulatory services, we can help you navigate the regulatory requirements through your product’s lifecycle. From working in a focused area supplementing your internal team, or assuming a lead role in undertaking your entire regulatory planning, our team is ready to serve you.

Regulatory experience you can count on.

NDA submissions
Regulatory strategy plans developed
NDA submissions managed

How can we help you?

  • Regulatory strategic planning and consultation
  • Target product profile (TPP) creation and review
  • Regulatory/industry intelligence
  • Gap analyses and due diligence
  • Label creation and review
  • Pediatric plan development
  • Agency interactions
  • US agent/authorized representative
  • Regulatory writing
  • Regulatory operations and publishing
  • CRO and vendor oversight
  • Ongoing post-approval support

Learn how three clients relied on Firma Regulatory Services to produce timely, quality, and successful regulatory submissions.

Learn how Firma Regulatory services can help you achieve new or generic product submissions and approval.