Estrategia reglamentaria
Increase your probability of success and de-risk your development
Minimize regulatory-related delays when we help you outline your timeline alongside your nonclinical, CMC and clinical requirements. Our regulatory strategy consultants help you navigate regulatory processes and programs and keep your asset moving forward.
Strategic partner for your program
Benefit from over 1,000 medical doctors, 1,000 PhDs and 16,000+ staff in over 100 countries—all focused on helping you achieve your commercial goals.
Integrated expertise
Our team supports 40+ agency meetings annually, providing you with experienced guidance and strategic advice to enhance your development process.
Comprehensive support
With ~50 market access & HEOR consultants averaging 10-25 years of experience, we deliver insights and solutions that optimize your regulatory strategy and product value.
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On June 26, 2024, the U.S. FDA’s draft guidance on improving diversity was published: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance was open for comments through September 26, 2024, and Fortrea provided comments.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 This draft guidance was open for comments through September 26, 2024, and Fortrea provided comments.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 of your data and guidance as we coordinate nonclinical laboratory testing with your selected vendor.
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CMC regulatory strategy
Development of your CMC plans, data review and writing services for CMC submission documents.
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Estrategia reglamentaria clínica
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
