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Regulatory Strategy Consulting

Develop a regulatory strategy that helps you proactively navigate product development complexities.

Get customized support to make the most of your meetings with regulatory agencies around the world.

Access a wealth of experience to support your regulatory goals across each phase of development.

Find the most appropriate regulatory path for your product.

Comprehensive planning significantly reduces the potential for regulatory-related delays by outlining your timeline alongside your nonclinical, CMC and clinical requirements. 

Even if you are planning to out-license or co-develop your product after proof of concept (PoC), our regulatory strategy consultants can help you look ahead to navigate several regulatory processes and programs, outline your expectations as well as help you address any issues, such as a clinical hold, to keep your program moving forward.

Working side-by-side with our market access consulting and HEOR experts to ensure an optimal integrated stakeholder strategy, we offer vast experience implementing regulatory solutions spanning the spectrum of product development-from nonclinical to post-approval. We stay on the cutting edge of regulatory guidance and policies, in areas such as real-world evidence, digital health and software as a medical device (SaMD) as we support your regulatory goals at each phase and help you advance toward your commercial goals.

Nonclinical regulatory strategy

Get scientific review of your data and subsequent guidance as we coordinate nonclinical laboratory testing with your selected vendor.  

CMC regulatory strategy

We can help develop your CMC plans, review data and provide writing services to support CMC submission documents.

Clinical regulatory strategy

Count on our team to prepare your clinical development plan, provide strategic input for your clinical protocol designs and support the development of your expedited program applications. 

Improve your interactions with Health Regulatory Agencies worldwide.

Make the most of your interactions with Health Regulatory Agencies (HRAs) with our team as your guide. 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. Our experience spans:

  • United States and Canada: U.S. Food and Drug Administration (FDA); Health Canada
  • European Union: European Medicines Agency (EMA); Committee for Orphan Medicinal Products (COMP); Paediatric Committee (PDCO)
  • United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA) 
  • China: National Medical Products Administration (NMPA)
  • Japan: Pharmaceuticals and Medical Devices Agency (PMDA); Ministry of Health, Labour and Welfare (MHLW)

 

Get support with specialized regulatory processes.

You can leverage our experience working directly with regulators to efficiently navigate the regulatory landscape.

  • Submissions of Pediatric Plans, Diversity Plans, Fast Track, Breakthrough Therapy and RMAT designations in the US
  • Expanded Access/Compassionate Use globally
  • Orphan Designation in the US and the European Union
  • SAKIGAKE designation in Japan
  • Advanced therapy medicinal products (ATMP) designation and PRIority MEdicines (PRIME) in the European Union 

Whether you need us to review your existing data, request scientific advice from a Health Regulatory Agency or help you prepare for or facilitate your agency meetings, we know how to streamline your agency interactions at every stage of your development.

Ensure your development program starts with a sound regulatory strategy.

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