The development of new drug entities can be a complex and expensive project that requires a significant commitment of time and resources. The implementation of a sound development strategy and a detailed project plan can help to limit costs and reduce the time to successful completion of this process. Pacific BioLabs is committed to helping the Pharmaceutical Industry successfully navigate the nonclinical testing phases of this development process.
Preclinical and Nonclinical Consulting Services
Pacific BioLabs offers consulting services by preclinical scientists with extensive experience in nonclinical studies, including toxicology, metabolism and pharmacokinetics, and safety pharmacology, for the nonclinical development of new drugs. Our staff can assist in designing nonclinical programs for support of INDs to registration. As part of this support, we can prepare the nonclinical sections of the requisite regulatory submissions (IBs, INDs, briefing documents, etc.). Our expert staff can review your existing nonclinical package, i.e., perform a GAP Analysis , or conduct a review and critique of external nonclinical packages for in-licensing purposes.
Safety Toxicology and ADME Study Design and Review
Pacific BioLabs staff can assist in the conduct of your drug safety (Toxicology and Safety Pharmacology) and ADME (Absorption, Distribution, Metabolism and Elimination) studies. These services include study design, identification and qualification of contract research organizations (CROs), implementation and monitoring of studies at CROs, and review of results and conclusions (Reports).
Expert consulting services at Pacific BioLabs are available on a per hour or project basis, and include:
- Strategic design of nonclinical development plans
- Implementation, conduct and review of nonclincal development studies
- Preparation of the nonclincal portion of regulatory submissions
- Review of nonclinical programs for GAP Analysis and due diligence
Contact Pacific Biolabs for more information about our specific consulting expertise.