Novotech Nonclinical Toxicology Support: Regulatory Strategy & Submission Support

Novotech’s Nonclinical Toxicology Services provide biotech and pharmaceutical companies with strategic, end-to-end support. Leveraging extensive expertise across biologics, small molecules, vaccines, peptides, cell and gene therapies, Novotech designs customized nonclinical strategies aligned with FDA, EMA, PMDA, TGA, NMPA, and other global regulatory requirements. The Toxicology Services Team offers expert consulting on study design, safety assessments, and regulatory positioning, drawing on the experience of former GLP study directors. Support includes comprehensive drug development plans integrating nonclinical, CMC, clinical, and regulatory strategies; development strategy reviews; and gap analyses to ensure data readiness for ethics and regulatory submissions. Flexible engagement models range from project-based consulting to long-term strategic partnerships. Regulatory and submission support covers preparation and review of Investigator’s Brochures, construction of nonclinical sections for pre-IND, Type C, and global submission packages, and development of IND, CTA, IMPD, NDA, and BLA filings.

By integrating toxicology deliverables with protocol development, informed consent documentation, and site readiness, Novotech eliminates delays and ensures seamless regulatory alignment. With a proven track record of supporting successful global approvals and deep therapeutic expertise, Novotech delivers tailored toxicology solutions that de-risk development, accelerate timelines, and enable efficient market entry.