Services
Preclinical drug development consulting
Preclinical drug development consulting
Preclinical drug development consulting
- Comprehensive End-to-End Preclinical Expertise: Providing strategic consultancy across the full preclinical drug development process, from concept to IND/CTA readiness.
- Rational Study Design: Designing robust preclinical pharmacology, PK, and toxicology studies that meet regulatory expectations and strengthen investor confidence.
- GLP and
- Comprehensive End-to-End Preclinical Expertise: Providing strategic consultancy across the full preclinical drug development process, from concept to IND/CTA readiness.
- Rational Study Design: Designing robust preclinical pharmacology, PK, and toxicology studies that meet regulatory expectations and strengthen investor confidence.
- 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.
Regulatory development support
Preclinical drug development consulting
Preclinical drug development consulting
- 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.
- 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.
Target product profile (TPP) support
Preclinical drug development consulting
Target product profile (TPP) support
- 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
- 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, I help complete and maintain your TPP as a central roadmap for clinical development, regulatory planning, and commercialization.