How can pharmaceutical regulatory affairs services help me?
We will support you in achieving your goal with a study program that minimizes volume, cost, and animal use. Wherever possible, we select options including in silico assessments, read across, and the use of existing information to address data gaps. With the help of our pharma regulatory services, you can be confident that in vivo studies will only be utilized when there is no other option. Through our unwavering commitment to the 3Rs, we are advancing responsible science with a foundational fourth R — Responsibility. This fourth R, which was developed specifically for Charles River, ensures that we are placing a lens of responsibility on everything we do, driving progress or patients and animals that depend on our work.
Our Range of Pharmaceutical Regulatory Affairs Services
In addition to helping you find the most efficient path to dossier submission, our pharmaceutical regulatory affairs services can assist with:
- ICH M7 evaluation (DEREK, SARAH, Leadscope)
- N-Nitrosamine (NNA) impurities: Carcinogenic Potency Categorization Approach (CPCA) and Acceptable Intake (AI) derivation from (surrogate) substance-specific data
- ICH Q3 impurity qualification, including in silico assessments, use of data from structural surrogates (read across), and other alternatives to animal testing
- Compilation of Weight of Evidence on the added value of a two-year carcinogenicity study, based on the ICH 1SB(R1) Addendum
- Safety assessment of novel excipients
- Toxicological risk assessment (TRA) of extractables and leachables, based on ISO10993-17
- Worker safety (OEL/OEB setting)
- PDE derivation in shared facilities
- Preparation of position papers / expert statements / manuscripts for publication in peer-reviewed journals
- Specific requests from (Health) Authorities
Besides nonclinical pharmaceutical regulatory affairs services, we also provide consultancy for Chemistry, Manufacturing, and Controls (CMC) strategies and Environmental Risk Assessments (EA/ERA).
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Assistance with Your Regulatory Documentation
Please contact our pharmaceutical regulatory affairs experts for help with a range of tasks involved in compiling your regulatory documents. Our pharma regulatory services include:
- Writing of the non-clinical part of the IND/CTA or CTD
- Writing of Investigator’s Brochure (IB)
- Preparation of tabulated - and brief summaries
- CMC services; preparation of IMPD
- Submission of eCTD
- Pre- and post-submission regulatory support
Frequently Asked Questions (FAQs) About Pharmaceutical Regulatory Affairs Services
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What pharmaceutical regulatory affairs services do your team provide?
Our team offers pharmaceutical regulatory affairs services to guide you through the drug development process, including nonclinical module compilation for regulatory submission, scientific and regulatory document support, and more.
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What is your approach to reducing the need for in vivo studies?
Our pharma regulatory services can help you to minimize volume, cost, and animal use by utilizing in silico assessments, read across, and the use of existing information to address data gaps whenever possible.
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What kind of documentation submission assistance do you provide?
Our pharmaceutical regulatory affairs services cover assistance with CMC services, preparation of IMPD, submission of eCTD, and pre- and post-submission regulatory support.