Pharma-GPS consults for clients seeking assistance with design and
execution of all phases of development, but focuses on IND-enabling preclinical through POC clinical programs. We believe product development is an integrative process involving regulatory understanding, comprehensive and deep technical/functional expertise, consumer understanding, and efficient program execution. Our experts in CMC product development, toxicology, pharmacokinetics, regulatory, and clinical trial design and analysis have years of experience as part of team-based development programs.
Our specialty is helping companies design programs linked to clear exit strategies and/or investor-specified goals.
Goal-Oriented FocusMany of our clients are start-up companies funded by or seeking investors, and need development objectives to be closely aligned with investor goals. By emphasizing goal-oriented development programs not driven entirely by regulatory milestones, clients are better positioned to generate funding and increase the value of their opportunity for any given exit point.
Managing the Regulatory Complexity
Through our knowledge and application of international regulatory guidances, experience with successful IND/CTA/NDA/MAA filings, and addressing of agency questions, and complemented by our partners in the US, EU, Japan, and China, Pharma-GPS offers the expertise to navigate the regulatory complexity of global projects.
Multinational or Chinese CROs/CMOs?
We have experience working with all the major multinational CROs/CMOs and use this knowledge to benchmark the CROs/CMOs we have visited and audited during our time in China. We do not believe at this time that Chinese CROs/CMOs are capable of conducting all phases of preclinical/clinical programs, but do believe that for specific objectives, China offers considerable cost and/or time savings. We seek to match these capabilities to clients' strategic development needs. Some examples of where it makes sense to consider China include:
- IND-enabling toxicology and pharmacokinetic studies, especially where monkey is the non-rodent species
- Phase 1 clinical studies, in particular those to support ADNAs or 505(b)(2) filings
- Phase 2 POC studies for indications not requiring extensive ethnic bridging (e.g., dermatological products)
We help identify and qualify CROs/CMOs, design protocols, negotiate price, monitor, and supervise report writing for contracted studies in the US or China. For Chinese contracted studies, we offer ease of informational exchange through our bilingual staff, on-site monitoring, and assurance the final report will have the content and be in a format acceptable to regulatory agencies.