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Quality Systems News
 
From FDA News March 5, 2009
 
Issued today by FDA and EMEA - Guideline on Development, Production, Characterisation, and Specifications for Monoclonal Antibodies and Related Products
 
Tlachac served on the EMEA Biologics Working Committee to develop this new comprehensive guideline.
 
 
 
Respond to Your 483
 
Develop a proactive, thorough and responsive approach following visits from the FDA.  Quality Systems has an outstanding record in developing and maintaining effective relationships with the Agency.  View a recent FDA presentation.http://www.fda.gov/cber/summaries/pharma0109ar.pdf
 
EMEA Guideline on Monoclonal Antibody Manufacturing
 
The Parenteral Drug Association has just published in the PDA Letter, http://www.pda.org/MainMenuCategory/PDAMembership/PDALetter.aspx, a summary of the Revised EMEA Guideline on Monoclonal Antibody Manufacturing.  Tlachac served on teh Biologicals Working Party (BWP) Scientific Discussion.  A complete article regarding the outcome of this discussion may be found at www.pda.org/news.
 
Read about a major therapeutic protein development program
 
http://www.minnesotapartnership.info/pressreleases/2008-0417/

 
Announcements
 
Quality Systems has recently expanded its offerings to now include full development of therapeutic peptides for Phase I/II clinical trials.  Contact us to learn more about our very cost effective approach that will get your firm or institution into Phase I clinical trials