Non-Clinical Services - Overview
Non-clinical modules/documents are essential components of any Regulatory submissions for Pharmaceuticals. Some of the critical Regulatory decisions are based on non-clinical aspects of Pharmaceutical development and the logical presentation of the information in the Regulatory submissions. Therefore, the quality of non-clinical documents and modules in any Regulatory submission must be of the highest standard to ensure success.
As an expert and trustworthy Regulatory partner, our non-clinical team has played a pivotal role in facilitating high-quality non-clinical writing for numerous Regulatory submissions. Our team is involved right from the beginning of any development program by contributing to strategic decision-making and designing a robust non-clinical development plan most appropriate to the type of your product. Our experienced and qualified scientists, non-clinical experts, and toxicologists ensure that your non-clinical documents are developed in full compliance with applicable Regulatory guidelines and submission-specific requirements.
Our non-clinical 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 repurposing of already approved drug products (505(b)(2) or hybrid).
In early drug development, Freyr stands out for our expertise in Non-Clinical Regulatory Writing. With precision, we manage strategic decisions, safety studies, and Regulatory documentation, propelling your drug development journey forward.
Our detailed Non-clinical Service portfolio includes:
Non-Clinical Services
- 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
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- 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
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