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Advanceutics - Home : Pharmaceutical Consultant CMC QbD LCM

Advanceutics 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.

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Advanceutics - Home : Pharmaceutical Consultant CMC QbD LCM | advanceutics.com Reviews

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Advanceutics 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.

<META> KEYWORDS

1 Pharmaceutical Development

2 Pharmaceutical Manufacturing

3 QbD

4 Regulatory CMC

5 Pharmaceutical consultant

6 CMC consultant

7 CMC (Chemistry/Manufacturing/Controls)

8 small molecules development

9 Project Management

10 Process development

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advanceutics inc,select,biography,services,clients and,project profiles,useful links,welcome,and in europe,site map,designed by apps4all,for advanceutics

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Advanceutics - Home : Pharmaceutical Consultant CMC QbD LCM | advanceutics.com Reviews

https://advanceutics.com

Advanceutics 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.

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advanceutics.com

1

Advanceutics - Services : CDMO Selection Scientific Management Consulting Drug Product Development Quality by Design Regulatory CMC

http://www.advanceutics.com/services.html

Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC. Summary of Track Record. Patents, Publications, and Patents. Small molecule drug development. Key aspects of CMC: Drug Substance, Drug Product, Analytical, and Packaging, Quality by Design, Regulatory CMC. CMC Development, Manufacturing, and Packaging to support. Early Stage: Pre Phase 1 to Initial IND and Phase 1 studies. Mid Stage: Phase 2 and Phase 3. Registration: NDA / MAA submission, Process Validation, PAI preperation. Assis...

2

Advanceutics - Clients : Pharmaceutical Consultant San Francisco bay area CMC QbD LCM small molecule drug development

http://www.advanceutics.com/clients.html

Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC. Summary of Track Record. Patents, Publications, and Patents. 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 and manufacturing organization (CDMO) based in San Francisco bay area, CA. Several publicly traded companies in San Francisco bay area. Parenteral lyophilized pro...

3

Advanceutics - Track Record : Pharmaceutical Development Manufacturing QbD Regulatory CMC

http://www.advanceutics.com/about_trackrecord.html

Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC. Summary of Track Record. Patents, Publications, and Patents. About 20 years in industry; 13 years in management functions for CMC, Pharmaceutical Development and Manufacturing. More than 6 years experience as Sr. Director / Ex. Director in leading integrated CMC functions (API, drug product, analytical development, packaging, scale-up, validation, launch manufacturing, LCM, and BD support). CMC Leadership and Project Management:.

4

Advanceutics - Biography : Pharmaceutical Consultant CMC QbD LCM small molecule drug development San Francisco bay area

http://www.advanceutics.com/about_biography.html

Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC. Summary of Track Record. Patents, Publications, and Patents. Oct 2009 - Present). University of Pacific, Stockton, CA. Apr 2003 - Present). Adjunct Professor, Department of Pharmaceutics and Medicinal Chemistry. CV Therapeutics Inc., Palo Alto, CA. Sep 2001 Jun 2009). Executive Director, Pharmaceutical Development (Jan 2008 Jun 2009). Sr Director, Product Development and Manufacturing (Jan 2004 Dec 2007). Jan 1993 Aug 2001). Sr Che...

5

Advanceutics - Site Map : Pharmaceutical Consultant CMC QbD LCM small molecule drug development San Francisco bay area

http://www.advanceutics.com/sitemap.html

Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC. Summary of Track Record. Patents, Publications, and Patents. Summary of Track Record. Patents, Publications, and Patents. Clients and Project Profiles.

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Advanceutics - Home : Pharmaceutical Consultant CMC QbD LCM

Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC. Summary of Track Record. Patents, Publications, and Patents. 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. And welcome a chance to discuss your specific needs.

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