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
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.
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.
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.