Regulatory Consulting

Industry leaders with comprehensive submission experience to strategically position your product

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Moving you to the next phase

Regulatory professionals who guide you throughout your study

Regulatory Professionals, A Division of Premier Research, offer full-service strategic and tactical product development expertise in all stages of drug development. Our regulatory consultants are with you throughout the development of your drug, biologic, device, drug-device combination, or diagnostic. We offer:

  • Extensive experience with agency interactions, averaging 20-plus meetings per year
  • Consulting services aligned with agency thinking on drug/biologics/device development requirements
  • Functional services such as acting head of regulatory for start-up companies
  • Preparation of and review of clinical protocols, CMC amendments, and response to agency questions
  • Publishing and document management experience, including significant work with new drug applications, biologics license applications, marketing authorization applications, and rest-of-world submissions
  • eCTD submission process and expertise at every step of the approval process

From Phase 1 through post-marketing, we support trial design, regulatory submission, and compliance and have extensive experience preparing customers for major submissions and agency meetings.

Our experienced team can develop your:

  • Strategic development plans
  • FDA meeting preparation
  • IND preparation and submission
  • Orphan drug, breakthrough, and fast-track applications
  • Study design
  • Clinical study reports
  • Global safety database design
  • SAE reporting

From early-phase to late-stage development, our global product development team leaders synchronize multidisciplinary services, global development expertise, and insight from therapeutic thought leaders to create development strategies custom-fit to your needs.

  • Development planning
    • Regulatory agency strategies and IND maintenance
    • Study design to whole development plans
  • Infrastructure expertise
    • Data analysis and handling
    • Product/company safety database
  • Preferential regulatory pathways
    • Regional legal representation
    • Orphan applications
    • Accelerated or breakthrough planning

PREMIER INSIGHT 268

Six months to submission

The client asked the nearly impossible – a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it.

PREMIER PERSPECTIVE

Four common IND mistakes

Before starting Phase 1 trials, an investigational new drug application must be approved by the FDA. This critical step grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval.

Related Services

Look to our professional consultants for experience in quality management, biostatistics, and strategic development consulting.

Global Compliance

Biostatistics

Development Consulting

Check out our resource center

Our experts have developed an extensive library of white papers, case studies, blogposts, and other informative resources.

PREMIER INSIGHTS

PREMIER INSIGHTS

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WHITE PAPERS

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WEBINARS

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VIDEOS

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PODCASTS

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