Regulatory

|Regulatory
Regulatory2018-08-24T16:02:39+00:00
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.

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Regulatory experience you can count on.

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NDA submissions
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Regulatory strategy plans developed
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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 MORE ABOUT FIRMA REGULATORY SERVICES

Browse these resources to learn how you can produce timely, quality, and successful regulatory submissions.

MEET TIMELINES WITH FORMAL AGENCY REPRESENTATION AND SUBMISSION SUPPORT

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PRODUCE TIMELY, QUALITY, AND SUCCESSFUL REGULATORY SUBMISSIONS

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