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Margery Ross, PhD

Development QA - Biologics Early Phase GMP

 

Development QA - Biologics Early Phase GMP, a consulting firm
with a purpose:

  • Helping biologics start-ups choose and operate appropriate GMP quality systems.
  • Showing early phase biotechs how to build quality accountability
    and robust data integrity into pilot scale manufacture. 

 

Margery Ross

These companies often have less experience with quality systems due to focus on scientific and technical discovery.

 

GMP attention in early phase manufacture creates advantages in finding funding and, longer term, greatly strengthens the company's position for a successful pre-approval inspection.

 

Dr. Margery Ross, LLC Owner, provides clients her 7+ years experience in Early Phase GMP as QA head at Medarex, and over 22 years combined clinical and commercial quality experience including Johnson & Johnson (Ortho Biotech) and AAI Pharma.

 

Medarex manufactured numerous early phase clinical monoclonal antibodies in New Jersey,  1993 – 2010, including the revolutionary Yervoy, which won approval for BMS for melanoma in 2011.  BMS purchased Medarex in 2009.

 

 

 

 

 

Contact Info:

Company:
Development QA -
Biologics Early Phase GMP

Tel: (732) 616-5649

Email: approvedbyqa@developmentqa.com

Web: developmentqa.com

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

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