## [Non-Clinical Writing Services](/index%2Ephp/medicinal-products/non-clinical-writing-services) # Non-Clinical Writing Services We deliver compliant, high-quality documents, expert non-clinical consulting services, and responsive client support. [Request Non-Clinical Writing Support](javascript:void(0)) ## Non-Clinical Writing Services - Overview Quality of non-clinical documents and modules in any Regulatory submission must be of the highest standard to ensure success. Our non-clinical team has played a pivotal role in facilitating high-quality non-clinical writing for numerous Regulatory submissions. We ensure that your non-clinical documents are Regulatory-compliant at any step. Our non-clinical writing services experts have supported numerous programs encompassing a variety of submissions through pre-IND/CTA to NDA/BLA/MAA for novel Pharmaceuticals (NCE/NME or NBE) or drug product repurposing (505(b)(2) or hybrid). We make precise strategic decisions, conduct safety studies, and document your progress, propelling your drug product development journey forward. #### Expedite your submission with expert Non-Clinical support [Get in touch now](javascript:void(0)) #### Our Non-clinical Services include: - [Writing of Non-clinical Overview and Summaries](#ncs-section1) - [Writing of Non-clinical Sections in the Meeting Packages](#ncs-section2) - [Writing of Non-clinical Sections in the Investigator's Brochure (IB)](#ncs-section3) - [Writing of Weight of Evidence (WoE) for Carcinogenicity](#ncs-section4) - [Writing of Special Protocol Assessment (SPA) for Carcinogenicity](#ncs-section5) - [Abuse Liability Assessment](#ncs-section6) - [Non-clinical Consulting & Strategic Services](#ncs-section7) ## Non-clinical Overview and Summaries The Non-clinical Overview (Module 2.4) and the Non-clinical Summary (Module 2.6) in an eCTD submission are vital 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 across different agencies greatly helped many companies by substantially reducing their costs and timelines through waivers for 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 obtaining responses from the authority by providing them with sufficient background and educating them. ## 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 WoE assessment and 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](https://www.freyrsolutions.com/medicinal-products/clinical-and-non-clinical-consulting-and-strategic-services) 2. [Development and Review of Study Plans/Protocols for Non-clinical Studies](https://www.freyrsolutions.com/medicinal-products/clinical-and-non-clinical-consulting-and-strategic-services) 3. [Non-clinical Development Strategy for Regulatory Submissions](https://www.freyrsolutions.com/medicinal-products/clinical-and-non-clinical-consulting-and-strategic-services) 4. [Consultation on Non-clinical Issues in the Submissions](https://www.freyrsolutions.com/medicinal-products/clinical-and-non-clinical-consulting-and-strategic-services) 5. [Consultation and Responses to Regulatory Queries](https://www.freyrsolutions.com/medicinal-products/clinical-and-non-clinical-consulting-and-strategic-services) 6. [GLP Audits of Test Facilities](https://www.freyrsolutions.com/medicinal-products/clinical-and-non-clinical-consulting-and-strategic-services) 7. [CRO Identification and Qualification for Non-clinical Regulatory Studies](https://www.freyrsolutions.com/medicinal-products/clinical-and-non-clinical-consulting-and-strategic-services) ## Non-Clinical Writing Services - [Expertise](#mdv-1) - [Advantages](#mdv-2) - Project planning and on-time delivery of documents, including priority submissions - Non-clinical scientists with hands-on experience in conducting various non-clinical studies (pharmacology, DMPK, and toxicology) as study directors, study personnel, QA, or pathologists - Well-established systems and processes from initial planning to final submission - Quality check and multiple checkpoints to ensure accurate and reliable data in the submission - Expert review by highly experienced non-clinical experts ![Non-Clinical Writing Services ]() - Well-qualified and highly experienced non-clinical experts, including board-certified toxicologists (DABT and ERT) and pathologists - Experience in handling complex programs involving highly innovative products - Strategic inputs in appropriate decision-making ![Non-Clinical Writing Services ]() #### Expedite submission with our expert non-clinical support. 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