Services

• Comprehensive End-to-End Pre-clinical Expertise: Providing strategic consultancy across the full preclinical drug development process, from concept to IND/CTA readiness. 

• Program Management: Designing and planning robust preclinical pharmacology, PK, and toxicology studies that meet regulatory or investor expectations. 

• GLP and Non-GLP Study Oversight: Designing and reviewing both GLP and non-GLP studies to ensure scientific rigor, regulatory alignment, and a clear path toward successful clinical entry.

• Preclinical Planning & Alignment: Designing and aligning preclinical study plans to meet regulatory expectations and support a seamless transition toward clinical development.
 

• Regulatory Pathway Guidance: Navigating complex preclinical/ regulatory requirements, reducing barriers and smoothing the path to first-in-human clinical studies.
 

• Regulatory Documentation Support: Reviewing and supporting the preclincial preparation of key regulatory submissions (e.g., IND, CTA) to ensure readiness and increase the likelihood of approval for clinical investigation.

• Strategic TPP Creation: Developing comprehensive TPPs to guide program strategy, clarify development objectives, and ensure alignment across all stakeholders.
 

• Customizable TPP Templates: Providing a structured, easy-to-use TPP template tailored to the needs of the customer, from early-stage up to late-stage development programs.
 

• Ongoing TPP Support: From initial drafting to refinement, completing and maintaining your TPP as a central roadmap for clinical development, regulatory planning, and commercialization.