Regulatory Strategy

We refine, plan, and execute your product development strategy

Understanding the global regulatory landscape is critical for your program, and our Regulatory Strategy and Submissions team has the experience and expertise to develop a regulatory strategy that will ensure the efficient and timely execution of your product development program.

Our regulatory scientists enjoy partnering with clients for the long haul, from early development discussions about a diamond in the rough through to marketing application development, Advisory Committee meetings, and late-stage negotiations with the regulators. Along the way, we leverage our decades of experience with many product classes and therapeutic areas to help you identify the most expeditious and sensible regulatory/development strategy and key gaps, risks, and mitigations to make your program successful.

Our regulatory strategy services include:

  • Early development support

    Focus on big-picture regulatory planning for efficient and successful development:

    • Early development gap analyses and integrated product development plans.  IPDPs lay out a comprehensive development proposal founded on regulatory strategy and an overall clinical development plan to meet that strategy. Plus, they provide nonclinical and manufacturing plans to meet and support the clinical development plan
    • INTERACT, pre-IND, and pre-IDE meetings
    • IND/CTA development (along with publishing, submission, and maintenance)
  • Mid-stage support

    Focus on high-return activities to speed development and position product for regulatory success as the clinical and nonclinical data accrue:

    • Strategic data reviews & mid-stage gap analyses
    • US Type A, EOP1, EOP2 and other Type B topics, and Type C meetings, Special Protocol Assessments; EU Scientific Advice
    • Special regulatory designations: US Orphan, Fast Track, Breakthrough Therapy, Regenerative Medicine and Advanced Therapy, Qualified Infectious Disease Product, Accelerated Approval and Priority Review; EU Orphan, Prime, and ATMP designations
  • Late-stage support

    Focus on sound planning for successful marketing application execution:

    • Pre-submission meetings and EU Rapporteur meetings
    • Overall global submission program planning; individual regional submission project planning including study data submission plan, data pooling plan, chronological allocation of resources to develop submission efficiently
    • Key messaging development and plan for integrating messages into each component document in a marketing application
    • Full submission execution, including biometrics to produce integrated datasets and submission document data displays, dataset preparation and publishing, document authorship, publishing, and final submission. Submissions include 505(b)(1) NDAs, 505(b)(2) NDAs, 510(k)s, PMAs, BLAs, and supplements, MAAs (EU), NDSs (Canada) and other ex-US submissions
    • Advisory Committee meeting planning and support (back-room and bench)
    • Labeling and other negotiations with regulators

Our Experience

We have led

30+

marketing applications in the last 5 years

Last year, we submitted

7%

of all marketing applications to FDA

We have represented

30+

clients at FDA meetings in the last 3 years

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Considerations for Regulatory Strategy Development

To properly inform, develop, and manage the operational plans and execution of the activities across all disciplines in your development program, your comprehensive Regulatory Strategy should include the following critical components, and should be maintained and revised appropriately as development progresses:

  • Target Product Profile, including target indication and key elements of labeling
  • Summary of Applicable Law, Regulations, and Guidances (Regional and Global)
  • Identification of regulatory pathways in targeted regions and overall Global Submission Strategy, including targeted regulatory submission dates for clinical trial applications and marketing applications, and considerations for relationships and potential synergies among submissions across different regions for a global development program (i.e., strategy for harmonized submission development)
  • Assessment of options for accelerated development and approval
  • Assessment of approved precedent products, including strategic review of previous regulatory agency approval documents (for example, FDA Summary Basis of Approval, European Public Assessment Report)
  • Strategic Assessment of clinical and nonclinical studies required for each phase of development
  • Identification of key Go/No-Go decision criteria
  • Regulatory Authority meeting plans for scientific/regulatory advice and pre-submission meetings
  • Running log of all regulatory authority advice, including all comments, questions, and agreements, and noting any unfulfilled requests
  • Regulatory risk management plan (identification and mitigation of key regulatory risks)
  • Lifecycle management strategy

Accelerating Regulatory Approvals

What you really need to know about FDA’s Accelerated Approval, Breakthrough Therapy,
Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review programs

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Webinar

Tips for a Successful NDA Submission

Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market.  This webinar will share tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.

Watch webinar
David Shoemaker
Presenter

David Shoemaker, Ph.D.

Senior Vice President, R&D

Rob Woolson
Presenter

Rob Woolson

Chief Strategist, Biostatistics & Standards for Regulatory Submissions

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