to shift activity back to the U.S., including rising wages in
China and India and consumers demanding contact-center
service from agents who speak American-accented English
and Latin American Spanish.
Outcome-based pricing is another trend gaining traction
among highly experienced clients and outsourcers who have
built mature relationships with their CMOs.
Paying for a predetermined business result among partner
companies, means executing on contracts that have a slid-ing-scale of rewards for approaching desired outcomes—the
advantage of this trend is that it won’t lock providers into an
adverse all-or-nothing scenario.
After a decade-long period of consolidation, acquisition
and restructuring, the short-term thinking that drove the out-
sourcing movement as an effective means of boosting profit-
ability is evolving. The fact that India and China still lead the
list of GMP violators underscores the time and effort required
to affect a paradigm shift regarding quality. The short-term
cost savings realized from outsourcing to India and China is
losing ground to the value of quality of these services and on
business performance. Performance-based contracts should
have an impact on contract organizations that want to woo
multi-nationals. For now, all contract organizations would do
well to shift their focus to demonstrating compliance compe-
tence rather than being the lowest cost producer. ■
1. India and China top 2013’s GMP failures, according to EMA
data. By Dan Stanton, 08-Jan-2014, wwww.in-pharmatechnolo-gist.com
2. 2014 Nice Insight Annual Pharmaceutical and Biotechnology
Outsourcing Survey http://www.niceinsight.com/
ABOUT THE AUTHOR
Bikash Chatterjee, is President and Chief Technology
Officer of Pharmatech Associates Inc.
He has been involved in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30
Mr. Chatterjee has guided the successful approval of over
a dozen new products within the U.S. and Europe and is a
frequent speaker at industry and regulatory events. He has
published and is a regular editorial contributor to several internationally recognized industry journals. Mr. Chatterjee has
spoken and published extensively on the application of PAT,
Lean Six Sigma, Quality by Designand Process Validation approaches within the regulated life sciences industry.
Mr. Chatterjee holds a B.A. in Biochemistry and a B.S. in
Chemical Engineering from the University of California at San
A History Steeped in Innovation.
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