Regulatory Strategy
Increase your probability of success and de-risk your development
Our regulatory strategy consultants help you streamline your development program, eliminating repetitive testing, looking for novel pathways to approval, and navigating the global regulatory processes and programs. By planning ahead, asking the right questions and helping you have the answers and data you need to keep your asset moving forward towards approval.
Strategic ally for your program
Benefit from over 600 medical degrees, over 840 Doctorates and 15K+ staff in about 100 countries – all focused on helping you achieve your commercial goals.
Integrated proficiency
With 60+ regulatory consultants averaging 20+ years of experience, we deliver thoughtful strategies and proactive solutions that optimize your regulatory strategy and likelihood for product development success.
Comprehensive support
Our established relationships with regulators supporting 40+ agency meetings annually enables a deep understanding of the evolving global regulatory frameworks, providing you with experienced guidance and strategic advice to enhance your development process.
Leading the way on Diversity Action Plans
On June 26, 2024, the U.S. FDA’s draft guidance on improving diversity was published: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance was open for comments through September 26, 2024, and Fortrea provided comments. Until the final version is published, it replaces the FDA’s previous guidance published in April 2022. This draft guidance was open for comments through September 26, 2024, and Fortrea provided comments. Until the final version is published, it replaces the FDA’s previous guidance published in April 2022.
“Since July 2023, we have we have led the preparation of >50 Diversity Action Plans (out of 285 total the FDA has reviewed) which in great majority had been submitted to the FDA by the sponsors. We are actively gathering the FDA’s feedback to better prepare for studies that will start once approval of a Diversity Action Plan is mandated,” said Beatriz Rocha, MD, PhD, Chief Regulatory Liaison Officer at Fortrea.
The Fortrea Regulatory Strategy Consulting team closely tracks the U.S. regulatory landscape to understand how other regulatory agencies (e.g., EMA and MHRA) are working to meaningfully improve the diversity & inclusion of clinical trial
Get the phase-specific strategy you need
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Nonclinical regulatory strategy
Scientific review and gap analysis of safety toxicology, nonclinical programs, your data and guidance to support clinical studies and regulatory filings, as we coordinate nonclinical laboratory testing with your selected vendor.
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CMC regulatory strategy
Formulation development strategy and gap analysis to assess CMC requirements that support regulatory filings throughout all phases of development, plus data review and writing services for CMC submission documents.
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Clinical regulatory strategy
Design and identify the right regulatory path for moving your asset through all stages of development. Preparation of your clinical development plan, strategic input for clinical protocol designs and support for expedited program applications.
Navigate global health regulatory agencies with confidence
Be prepared and maximize your Health Regulatory Agencies (HRAs) interactions with our expert guidance. We lead an average of 40-50 agency meetings worldwide each year—supporting products across all phases of development—and spanning many different objectives and needs, including:
- U.S. and Canada: U.S. Food and Drug Administration (FDA); Health Canada
- EU: European Medicines Agency (EMA); Committee for Orphan Medicinal Products (COMP); Pediatric Committee (PDCO)
- U.K.: Medicines and Healthcare products Regulatory Agency (MHRA)
- Regulatory strategy consulting: Access strategic advice for regulatory development pathways
- China: National Medical Products Administration (NMPA) Japan: Pharmaceuticals and Medical Devices Agency (PMDA); Ministry of Health, Labour and Welfare (MHLW)
Get specialized regulatory process support
Submissions of pediatric plans, diversity plans, Fast Track, Breakthrough Therapy and RMAT designations in the U.S.:
- Expanded access/compassionate use globally
- Orphan designation in the U.S. and EU
- SAKIGAKE designation in Japan
- Advanced therapy medicinal products (ATMPs) designation and PRIority MEdicines (PRIME) in the European Union
Insights
Get the latest updates on Regulatory Strategy
A clear regulatory strategy: Maximizing development productivity by keeping the end in mind
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Diversity Action Plans: regulatory requirements and clinical trial enrollment goals
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Developing comprehensive strategies to assess abuse liability/potential of brain-penetrant compounds
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Efficiently managing manufacturing and R&D supply chain documentation and technical support writing for cosmetic, personal care and over-the-counter products
The role of Material and Product Support Services (MPSS) at Fortrea
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Advanced therapies: The advantage of early and frequent regulatory interactions
Navigating the dynamic regulatory environment in cell and gene therapy development involves a complex and iterative process.
Read Advanced therapies: The advantage of early and frequent regulatory interactions
Addressing challenges of data management for cosmetic, personal care and over-the-counter products
Read Addressing challenges of data management for cosmetic, personal care and over-the-counter products
Preparing and looking ahead for the Clinical Trials Regulation and CTIS
Stay informed with Fortrea’s blog on clinical trials regulation and regulatory updates. Prepare for upcoming changes and ensure compliance in clinical research.
Read Preparing and looking ahead for the Clinical Trials Regulation and CTIS