Can you help me sort out our complex regulatory requirements?

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.

400+

regulatory affairs and quality assurance professionals

30+

regulatory inspections per year

8500+

GLP studies per year

32+

led/attended meetings with regulatory agencies on behalf of clients

20000+

audits per quarter

161

IND Programs submitted to agency in 2019

Video: Standard Exchange for Nonclinical Data (SEND)

SEND is an implementation of the CDISC Study Data Tabulation Model (SDTM) that provides a framework for the standardized, electronic representation of individual animal study data. SEND is intended to increase the effectiveness and efficiency of data review for regulatory submissions. Involved with CDISC SEND from the beginning, our team is uniquely qualified to guide your SEND preparations and assist with dataset delivery.

eGuide: Investigational New Drug Development Programs

Evolving market pressures are changing the focus of the drug development industry, further accelerating early phases in order to create late-stage pipeline growth. Download our IND eGuide to understand how and when to plan your preclinical IND-enabling program as an integral part of meeting specific milestones necessary to timely and efficient IND submission.

Whitepaper: Need to Accelerate Drug Development? What Are You Missing?

Learn how to minimize risk and speed time to the clinic by widening your scope, answering critical questions early on, and collecting essential data that is sometimes overlooked.

Webinar: Succeeding With New SEND Requirements

Are you still facing challenges with SEND? Compliance with SEND requirements is not an option. If you’re struggling with implementing standards, have questions about the new guidances, or simply want to know what’s coming next, you don’t want to miss this webinar.

Eureka Blog: How Predictive Toxicology is Influencing Regulatory Approaches

In this blog post, our scientific advisors explain how new non-animal models and a weight of evidence approach could reduce the amount of animal testing required by regulators

Article: Regulatory Challenges of Medical Device Development

Read how Charles River is using its scientific diversity, experience, and regulatory expertise to design custom programs that suit the unique specifications of medical devices and satisfy global regulations.

Webinar: Regulatory Considerations for Environmental Risk Assessment

Both the US and European regulatory authorities require pharmaceutical companies to assess the potential impact of their drug substance on the environment. In this first of a two-part webinar series, learn about the regulatory requirements that will impact your ERA program design.

eGuide: REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals)

REACH is complicated, but your program to achieve compliance doesn’t have to be. The regulatory experts at Charles River have created an informative e-guide to help you understand requirements, avoid common pitfalls and develop an effective strategy to register your chemicals successfully and on time.

Whitepaper: EMA Revises the Guideline for Environmental Risk Assessment of Medicinal Products for Human Use

In preparation for the release of the final draft revision, Charles River’s team of scientists analyzed the ERAs for substances assessed between the guideline’s last publication date (2006) and the current day to determine the impact of proposed guideline changes on previously conducted studies. Download this whitepaper for a summary of changes, as well as the results of our investigation.

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