Quality by Design: is it only for the big guys?

June 6th, 2012 by

There has been a lot of discussion at conferences and on LinkedIn as to whether QbD is just for big Pharma and Biotech and whether smaller companies are being discriminated against.  This triggered me to write an article for Metric Streams, GXP Lifeline.  Enjoy

One thought on “Quality by Design: is it only for the big guys?

  1. Dear Gentlemen

    I am sometimes working as bio-process consultant, so, I have interesting about your solution.
    Let me know possibility become your partner for Korean market and some other Asian market.
    I am working as exclusive distributor for Intelligen products for Korea, China, Hongkong and Taiwan.

    BTW, one of our customer want to work with our company after Biofors Global organize international consortium team with renown foreign consultant as a member of projects team for CMC documents provide based on ICH Q8(R2), Q9, Q10, and Q11 especially for QbD documentation.

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    Best regards

    Kevin KB Rhee

    Chief Engineer of Process R&D Institute of Biofors Global Inc.

    Bucheon TechnoPark 300-308, #345 Suckchonro, Ojunggu, Bucheonsi, KyunggiDo 421-809

    Tel. +82-32-323-6851, CP +82-10-9415-0786, Fax. +82-32-323-6852

    http://www.biofors.co.kr http://www.intelligen.co.kr http://www.intelligen.com rheekeebung@gmail.com

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