Advanceutics Inc. Information

Advanceutics Inc. was founded in October 2009 with a mission to advance the needs of emerging and established pharmaceutical companies in the broad areas of pharmaceutical development, manufacturing, incorporating QbD elements in development cycle, CMO selection and management, and regulatory CMC. Since 2009, Advanceutics Inc has consulted with about 20 companies based in San Francisco bay area and in Europe. Consulting assignments varied from early stage, mid stage, late stage, registration and post approval initiatives. We offer strategic, tactical, and 'hands on' support for developing and executing CMC plans of small molecule programs to advance formulation & process development, manufacturing, packaging clinical and stability batches, scale-up & technology transfer, process validation, bulk manufacturing for commercial launch, post approval CMC changes, and Life Cycle Management (LCM) Initiatives. To compliment development and manufacturing plans, we integrate and leverage regulatory guidance, asses and improve drug product specifications, review and improve plans for CMC registration plans, help prepare EOP2 CMC briefing packages, help companies in successful transition from Phase to Phase 3 from CMC perspectives, and do "heavy lifting" in drafting drug substance and drug product section in IND, NDA, MAA. We also offer due diligence preparation and assessment for in / out licensing opportunities. Our expertise provides the assurance of success, with a philosophy of getting it right the first time, emphasizing speed, timeliness, and flexibility, and cost containment. We are located in the San Francisco bay area and welcome a chance to discuss your specific needs.