Regulatory Strategy

We build tailored global regulatory strategies that minimize risk, accelerate development, and align with health authority expectations.

A regulatory strategy meeting occurring.

Build Your Regulatory Roadmap with Confidence

We provide global regulatory strategy consulting that spans the entire product lifecycle—from initial preclinical through marketing applications to post approval and lifecycle management. Whether you are planning for a first-in-human study, seeking orphan drug designation, or preparing for global marketing authorization, our experienced team can help you build a roadmap to minimize risk and expedite your program, across all stages of product development.

What We Offer

We offer end-to-end regulatory strategy and submissions support for drugs, biologics, advanced therapies, medical devices, diagnostics and combination products, tailored to your product type, target indication, geographic scope, phase of development, and corporate goals. Our services and capabilities include:

Global Regulatory Strategy Development and Regulatory Pathway Assessment

We build comprehensive, stage-appropriate regulatory strategies for early preclinical development through marketing applications. Our services include:

  • Regulatory pathway analysis and product classification
  • Global development strategy and regional positioning
  • Assessment of expedited pathways
  • Orphan designation and rare disease strategy
  • Gap analyses for development and submission readiness
  • Pediatric strategy and PIP/PSP planning and development
  • Risk mitigation planning and regulatory precedent reviews

Scientific Advice & Health Authority Interactions

We prepare and lead productive interactions with regulatory authorities to ensure productive dialogue and clarity on development expectations.

  • Meeting request and briefing document preparation
  • Full support for FDA meeting planning and execution across all meeting types including INTERACT, Pre-IND, EOP1, EOP2, pre-NDA/BLA, and other meetings
  • Full support for Scientific Advice and pre-submission meetings in Canada, Europe, and other regions
  • Coordination of all meeting-related activities and strategic responses to agency feedback

Clinical Trial Applications

We provide end-to-end regulatory support for clinical trial applications under global frameworks including US INDs, EU CTAs under CTR/CTIS, UK CTAs to MHRA, Canada CTAs, and more.

  • IND/CTA strategy and submission planning
  • Country-level regulatory intelligence
  • Dossier preparation and submission, including authorship of all regulatory, clinical, and administrative submission documents (IND, CTA, IMPD, IB)
  • IND/CTA maintenance and life cycle management

Marketing Application Strategy and Submission

From pre-submission planning through peri-approval support during agency review and post-approval life cycle management, we help you prepare for a successful submission and guide your program through the final regulatory hurdles to approval.

  • Gap assessment to determine readiness for marketing application and identify and mitigate potential filing risks
  • NDA/BLA/NDS/MAA strategic planning and final pre-submission negotiations with regulatory authorities
  • Full support for data integration and analysis to prepare integrated analyses of efficacy and safety data per regulatory authority guidance and recommendations
  • Development of proposed labeling (US Prescribing Information, Canada Product Monograph, EU SmPC)
  • Preparation and submission of dossiers in electronic Common Technical Document (CTD) format, including comprehensive submissions management support; authorship of Module 1, Module 2, Module 3, and Integrated Summaries of Safety and Efficacy; and compilation of reports in Modules 4 and 5
  • Comprehensive support for 510(k) submissions
  • Development of accelerated/conditional approval strategy
  • Lifecycle management (supplements, variations, renewals, labeling updates)

Why Choose Everest for your
Regulatory Strategy?

Therapeutic and Regulatory Expertise

Our team of regulatory strategists, former regulators, and scientific experts bring deep experience in small molecules, biologics, ATMPs, and combination products.

A woman shaking hands with a man.
Kevin Barber 2

Team Leadership

Kevin Barber, Ph.D., M.S., RAC, PMP

Throughout his 30-year career, Kevin has successfully supported over 80 development programs and played a key role in 18 product approvals worldwide. He has prepared and filed more than 100 INDs/CTAs and contributed to over 80 marketing applications across the United States, Canada, Europe, Latin America, Australia, and New Zealand. His extensive therapeutic expertise spans oncology, CNS/neurology, immunology, cardiovascular disease, infectious diseases, dermatology, and cell/gene therapy.

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