At X Pharma Plus, we deliver high-quality non-clinical documents that support Regulatory submissions from pre-IND/CTA meeting requests to complex NDA/BLA/MAA submissions. Our dedicated team of non-clinical experts ensures compliance with global Regulatory requirements, offering strategic guidance and timely, accurate documentation.
Non-Clinical Services – Overview
Non-clinical modules are critical components of any Regulatory submission. Key decisions in drug development rely on non-clinical data, making accurate, well-structured documents essential for submission success.
At X Pharma Plus, our experienced scientists, pharmacologists, DMPK specialists, and toxicologists provide comprehensive non-clinical support. From strategic planning in early drug development to the preparation of submission-ready documents, our experts ensure Regulatory compliance, scientific rigor, and consistent messaging across all non-clinical modules.
We support diverse product types, including novel Pharmaceuticals (NCE/NME or NBE) and repurposed drugs (505(b)(2)/hybrid submissions), across multiple Regulatory authorities worldwide.
Non-Clinical Services
“Comprehensive support for preclinical development, including pharmacology, toxicology, and safety assessment studies, along with preparation of regulatory-compliant documentation to ensure smooth progression to clinical phases and regulatory approval.”
- Writing Non-Clinical Overviews and Summaries (Modules 2.4, 2.6, 4)
- Non-Clinical Sections for Meeting Packages (pre-IND/CTA, pre-NDA/BLA/MAA)
- Non-Clinical Sections of the Investigator’s Brochure (IB)
- Weight of Evidence (WoE) Assessments for Carcinogenicity
- Special Protocol Assessment (SPA) for Carcinogenicity Studies
- Abuse Liability Assessments
- Non-Clinical Consulting & Strategic Services
- Scientific and Regulatory Review of Non-Clinical Documents
- Study Plan/Protocol Development and Review
- GLP Audits and CRO Qualification