Global 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. Our regulatory consulting services include:

  • 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.

SERVICES INCLUDE

  • 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

WEBINAR

Expedited drug development in the U.S. & Europe

Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It’s essential to start with the end firmly in mind, identifying the target population and defining elements of the program long before you dose the first patient.

PREMIER PERSPECTIVE

Changes in India’s drug and clinical trial rules

One reason for the slow growth of clinical research in India has been the country’s stringent regulatory requirements. The Ministry of Health and Family Welfare, responsible for all health policy in India, took steps to clarify these requirements and address many of sponsors’ concerns with the publication of its New Drugs and Clinical Trials Rules in 2019.

Premier Thought Leaders

Sameena Sharif

Sameena Sharif

President, RPI, A Division of Premier Research
Kristi Miller

Kristi Miller

Vice President, Regulatory Affairs Strategy, RPI, a Division of Premier Research

Related Capabilities

Adding value at every step in the process, we provide expertise in strategic product development, clinical R&D, and technology tools to ensure your trial’s data integrity, process efficiency, and timely analytics and reporting.

Strategic Product Development

Strategic Product Development

Clinical Research & Development

Clinical Research & Development

Premier Ecosystem

Premier Ecosystem

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

WHITE PAPERS

WHITE PAPERS

WEBINARS

WEBINARS

VIDEOS

VIDEOS

PODCASTS

PODCASTS

Connect with us

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