Scientific & Regulatory Advisory Services

Market pressures continue to change the focus and structure of the drug development industry with a heavy emphasis on accelerating preclinical development to move the most efficacious therapies into the clinic. The preclinical drug development journey is rarely straight and often requires course corrections and pivots. Our Scientific and Regulatory Advisors can help your program.

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Charles River consultants work tirelessly to help you navigate the drug development process as the route of a new drug, biologic, or device from concept to commercialization is rarely linear or easy.

Scientific Advisory Services

Charles River has built a unique team of Scientific Advisors whose expertise spans various therapeutics areas and stages in the drug development process. The mission of the scientific advisory service (SAS) team is to guide clients, every step of the way. With decades of industry experience and proven abilities to navigate the complex and changing regulatory landscape, the SAS team can design and manage lean and robust preclinical programs. The team provides flexible, responsive, and personalized support, and each client’s project is managed with the same dedication and attention as if it were our own. With access to the industry’s most comprehensive portfolio – from early discovery to market support – our team is uniquely qualified to map your journey through drug development.

Regulatory Advisory Services

In the fast-paced world of innovations and scientific advancement, the global regulatory landscape is always changing. Understanding the guidelines of your respective Regulatory Body is paramount for success. Our Regulatory Advisory Services (RAS) team will strategize, guide, and support your journey to a sustainable state of compliance and ensure you successfully meet business objectives and global regulatory and compliance requirements.

Our regulatory consulting team can help you keep track of the ever-changing regulations in various regions of the world, provide advice on legal requirements, develop a regulatory strategy for your product’s lifecycle, help interface with the relevant regulatory agencies, and assist in the preparation of required registration documents for market approval. Our experts have experience in the pharmaceutical, biotech, food, dietary supplement, and medical device industries throughout all stages of the product lifecycle.