I work with companies on Drug Product Commercialization, creating a Quality System for early and late clinical development, commercial manufacturing, and ensuring effectiveness of quality programs and documentation for compliance in a GXP international regulatory environment.
I help companies in four primary areas:
Strategically develop an effective CMC regulatory program
Evaluate and oversee capability of outside contract manufacturing organizations
Build and improve a phase appropriate GMP Quality System
Start-up of new GMP manufacturing space
I have spent over 40 years within the biopharmaceutical industry in direct development and commercialization of over 20 new drug products. I understand the market, understand your needs, and understand the amount of work invovled to bring ideas to light.
I work with companies to drive regulatory strategy, communications, submissions, and manage inspections to enable successful commercialization of products and manufacturing licensing.
