Can you help me sort out our complex regulatory requirements?

Simply, Yes.

With a team of Regulatory and Scientific Advisors we can help manage strategic, operational, and regulatory risk across multiple dynamic markets.

Navigating intricate regulatory requirements is one of the most challenging aspects of pharmaceutical, agrochemical, and industrial chemical product development. Our advisors are dedicated to protecting you from regulatory risk while anticipating and preparing for future challenges. Many are committee members for regulatory initiatives like ICH guidelines, REACH, and SEND and actively participate in local and global professional societies. Applying a collaborative approach and deep understanding of your product, they will shape the best regulatory and scientific strategy to advance your program across the life cycle of product planning, development, and regulatory submission.

Among our experts are former industry regulatory, scientific, and executive professionals who will assist in regulatory planning and applications to agencies around the globe for any type of product from small molecules to larger proteins, cell and gene therapies as well as viruses, nanoparticles, veterinary medicines, agrochemicals, food additives, and medical devices.

Within Charles River we ensure your program is kept on the right track by utilizing a risk-based auditing approach, conducting approximately 20,000+ audits per quarter for safety assessment studies alone. Governed by written policies that guide compliance, our robust data integrity program is built to minimize your regulatory risk and accelerate time to market.

regulatory affairs and quality assurance professionals
regulatory inspections per year
GLP studies per year
led/attended meetings with regulatory agencies on behalf of clients
audits per quarter
IND Programs submitted to agency in 2019
Start the Conversation