Discussion Room 



Posted by Dr. Gary Birdon 9/13/2018 2:08:36 PM

Recently, I have spent a large part of my time reading, writing, and trying to understand some of the major compliance issues I find in both 483s and Warning letters particularly noteworthy for companies from India and China.  While some may blame the ambiguous term "culture" for the problems, I believe there are at least three possible reasons which have not been fully considered for the number of significant 483s leading to Warning Letters in both India and China.

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Posted by John dr Jolleyon 9/4/2018 4:50:48 PM

This white paper identifies some of the socio-economic factors that are influencing growth in the pharmaceutical markets by introducing issues of affordability in both developed and emerging markets and comparing these with the effects of demand to identify the markets that are likely to see high growth.

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