Advanceutics Inc.
Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
Clients
- Consulted with about 20 companies since October 2009 including publicly traded and privately held drug delivery companies in San Francisco bay area and Europe.
- Formurex Inc, a privately held contract development & manufacturing organization (CDMO) based in San Francisco bay area, CA.
- Several publicly traded companies in San Francisco bay area.
- Several Privately held drug delivery companies in San Francisco bay area.
- Privately held companies, for developing NCE products, in San Francisco bay area.
- Privately held company specializing in development of ER ANDA products.
- Publicly traded company in UK.
- Publicly traded company in Switzerland.
- Advisor / Consultant to Academic Institutions:
- University of Pacific, Stockton, CA.
- Alliance Institute of Advanced Pharmaceutical Sciences and Health Sciences, affiliated with JNTU, Hyderabad, India.
Examples of some completed and current projects
- Consulting with a publicly traded company for:
- Pre IND development: Consulting for pre IND activities for NCE development candidate, preformulation and formulation at CDMO for Phase 1, Phase 2, and Phase 3 studies, DP sections in IND, etc.
- Solid oral product for NCE: DP sections in IND annual updates, EOP2 CMC, assist in technology transfer to business partner for phase 3 efficacy, compiled 80 page process development report, etc.
- Parenteral lyophilized product for NCE: Prepared Product Development Reports (~100 pages), consulting feedback on drug product specifications, QOS update, NDA readiness, assisted in CMC due diligence for BD, etc.
- Consulting with a privately held company specializing in ANDA ER products in managing CMO in the areas of process validation, and being Person in Plant (PIP).
- Consulted with a Switzerland based publicly traded company on drug product developmental aspects for a program in Phase 2 and for another program in pre IND phase.
- Consulted with a UK based CRO for services to optimize and innovate development at the interface of pharmaceutical sciences, clinical pharmacology, and regulatory sciences.
- Consulted with a privately held company in managing CRO and PIP for pre formulation, formulation development, analytical development, GMP manufacturing, stability, and drafting IND for poorly soluble drug with improved plasma exposure for repeat Phase 1 studies.
- Consulted with a privately held bay area company in transitioning from Phase 2 to Phase 3 for CMC aspects, planning and execution for CMC strategies for Phase 3 & ICH primary stability for registration at a Canadian CMO (500 Kg scale) - powder for reconstitution.
- Consulted with a publicly traded company for screening and identifying EU based CMO for commercial manufacturing and packaging of approved capsule product (500 Kg scale), developed regulatory bridging strategy via variation filing.
- Consulted with a privately held company for proof of concept feasibility development, including human PK study, for FDC oral product in cardio vascular space.
- Consulted with a publicly traded company for technical consulting in pharmaceutical (formulation and process) for development of highly potent and low solid oral product in support of phase II a efficacy studies.
- Consulted with a privately held delivery company focused on ocular drug delivery for compiling reports in development pharmaceutics and mfg process development.
- Consulted with CDMO based in CA for business development and scientific marketing.