Non-Clinical Writing Services

Non-clinical Overview and Summaries

Non-clinical Overview (Module 2.4) and non-clinical summary (Module 2.6) in an eCTD submission are vital and essential non-clinical documents as part of Regulatory submissions. Our experienced team of non-clinical experts has developed and submitted numerous non-clinical documents as part of different submissions to various Regulatory agencies worldwide.

Our non-clinical experts, comprised of pharmacologists, DMPK scientists, and toxicologists, have hands-on experience conducting non-clinical studies and vast experience in non-clinical Regulatory writing. Our experts ensure data accuracy during submission and consistency in messaging across documents. They are proactively involved in discussing and resolving any critical issues/findings to avoid potential submission delays.

Non-clinical Sections of the Meeting Packages

Our experience handling a variety of submissions while dealing with different agencies greatly helped many companies by substantially reducing their costs and timelines due to waivers from the conduct of unreasonable non-clinical studies.

Our vast experience in the pharmaceutical Regulatory domain has helped several clients develop the non-clinical sections of their pre-submission meeting packages. Our team of non-clinical experts has supported clients in getting equipped with responses from the authority by providing and educating the client with sufficient background.

Non-clinical Sections of Investigator's Brochure (IB)

With dedicated resource alignment, we ensure your IB is updated in a timely manner without pressure. Our non-clinical experts have vast experience developing new IBs for various product categories. In addition, we support several companies with continuous updates and maintenance of IB throughout product approval.

Weight of Evidence (WoE) Assessment for Carcinogenicity

In accordance with “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonization; Guidance for Industry,” which introduces a comprehensive and integrative WoE approach for carcinogenic substances. This scientific approach has substantially reduced carcinogenicity testing of Pharmaceuticals in animals. However, the sponsors must demonstrate that their product has zero or negligible carcinogenicity risk through a comprehensive assessment of WoE and can qualify for a waiver of carcinogenicity testing.

At Freyr, our non-clinical experts perform a robust assessment using their thorough knowledge and skills in pharmacology and toxicology to develop a high-quality WoE document for Regulatory submission.

Special Protocol Assessment (SPA) for Carcinogenicity

Post-WoE assessment, sponsors prioritize submitting a SPA document to the agency. Submitting the SPA and seeking the agency’s feedback on the proposed carcinogenicity study design is an excellent opportunity to avoid future rejection issues or study hold. Our toxicologists/non-clinical experts have very good experience handling and submitting high-quality SPA to the US FDA, including providing required supplementary data to facilitate the agency’s review process.

Abuse Liability Assessment

As per the FDA’s guidance, a thorough evaluation of the drug substance's abuse potential shall be carried out. The FDA encourages sponsors to consult with it throughout the drug development program regarding the appropriate assessment of abuse potential. The sponsor may also submit abuse-related questions or issues to the FDA.

In this regard, non-clinical experts at Freyr have helped several sponsors submit an abuse liability assessment with available data/evidence to facilitate the agency’s review and seek an appropriate response.

Non-clinical Consulting & Strategic Services

Our services include:

1. Scientific and Regulatory Review of Non-clinical Documents
2. Development and Review of Study Plans/Protocols for Non-clinical Studies
3. Non-clinical Development Strategy for Regulatory Submissions
4. Consultation on Non-clinical Issues in the Submissions
5. Consultation and Responses to Regulatory Queries
6. GLP Audits of Test Facilities
7. CRO Identification and Qualification for Non-clinical Regulatory Studies