Non-Clinical Services

Non-clinical Overview and Summaries

Non-clinical Overview (Module 2.4) and non-clinical summary (Module 2.6) besides Module 4 in an eCTD submission are vital and important non-clinical documents as part of your Regulatory submissions such as IND, CTA, NDA, BLA, and MAA. Freyr’s well-qualified and highly experienced team of non-clinical experts have developed and submitted numerous non-clinical documents as part of different submissions [like 505(b)(1) or 505(b)(2) to the FDA or equivalent to EMA and other countries] to various Regulatory agencies across the world.

Freyr’s non-clinical experts comprised of pharmacologists, DMPK scientists and toxicologists have hands-on experience in the conduct of non-clinical studies in addition to their vast experience in non-clinical Regulatory writing. Our experts not only ensure the accuracy of data/information in the submission but also ensure consistency in the messaging across documents.

Right from the initiation of the project, the project management or technical project lead keeps you updated regularly during document development and is proactively involved in discussion and resolving any critical issues/findings to avoid any potential delays in the submission.

Non-clinical Sections of the Meeting Packages

Asking the most appropriate questions as part of your pre-submission meetings is the best opportunity to plan and mitigate the actual submission strategy. Our non-clinical experts, with their vast experience in the pharmaceutical Regulatory domain, have helped several companies in developing the non-clinical sections of their pre-submission meeting packages like pre-IND/CTA, pre-NDA/BLA/MAA. Our team of non-clinical experts will help you ask the most relevant questions by providing sufficient background or rationale to the agency unambiguously and thereby help obtain clear responses and/or agreements from the authority. Our experience in handling a variety of submissions while dealing with different agencies greatly helped many companies on occasions by substantially reducing their cost and timeline due to waiver from the conduct of unreasonable non-clinical studies.

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

Drafting of a new IB or continuous updates or review of specific sections or an entire IB, our experts can handle all those nuances without any hassles. Our non-clinical experts are continuously engaged in one or other activity related to IB. With dedicated resource alignment, we ensure that your IB is updated on time without any timeline pressure. Our non-clinical experts have vast experience in developing new IBs for a variety of product categories. In addition, we also support several companies on continuous updates and maintenance of IB through approval of the product.

Weight of Evidence (WoE) Assessment for Carcinogenicity

Conduct of very resource-intensive carcinogenicity studies is one of the challenging tasks in the non-clinical development of pharmaceuticals. With the adoption of an addendum to guidance on testing for carcinogenicity, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonization; Guidance for Industry,” which introduces a comprehensive and integrative Weight of Evidence approach to assessing human carcinogenic (or having the potential to cause cancer) risk in drugs, there is a paradigm shift in the approach. Sponsors are no longer required to conduct very resource-intensive and unnecessary carcinogenicity studies for their product if there is no likelihood of potential carcinogenicity. The scientific approach recommended through this guidance has substantially reduced carcinogenicity testing of Pharmaceuticals in animals. However, the sponsors are required to demonstrate that their product has no or negligible risk of carcinogenicity through a comprehensive assessment of WoE and can qualify for waiver of carcinogenicity testing.

At Freyr, our non-clinical experts have helped several pharmaceutical companies develop high-quality WoE assessment documents for Regulatory submission and have received positive responses from the agency. Our experts perform a robust assessment by 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

Once the need for the conduct of carcinogenicity studies is established (either through the Weight of Evidence or by the nature of the product category), submission of a Special Protocol Assessment (SPA) document to the agency becomes a priority for the sponsors. Submission of SPA and seeking the agency’s feedback for the proposed carcinogenicity study design is a great opportunity to avoid any potential issues like disagreement on study design, dose selection, and parameters evaluated including possible rejection or non-acceptance of the carcinogenicity study data.

Consult Freyr if you need any assistance in the submission of Regulatory-compliant SPA for carcinogenicity studies. Our toxicologists/non-clinical experts have very good experience in 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 on the assessment of the abuse potential of drugs, a thorough assessment of the abuse potential of the drug substance shall be carried out. The process may well begin before an Investigational New Drug (IND) application or submission of a New Drug Application (NDA). The Controlled Substance Staff (CSS) in CDERs shall be consulted regarding the abuse potential assessment of a drug product. Although, every drug under development doesn’t need an evaluation of abuse potential NMEs with CNS activity that have not previously been assessed by the FDA for abuse potential must be evaluated for potential abuse liability. FDA encourages the sponsors to consult with FDA 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 requesting appropriate guidance from CSS. Interaction with CSS through the review divisions can occur from the pre-IND stage through the NDA review cycle.

There are some very critical aspects from non-clinical which have a high impact on the determination of the need for an abuse liability potential of NCE/NME. Non-clinical experts at Freyr have helped several sponsors with the submission of 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