Bioengineering

Ground Zero Pharmaceuticals Announces Expansion of Regulatory Consulting Services to South Africa

Published in Medical Letter on the CDC and FDA, October 28th, 2007

The advent of biosimilar drugs, new combinations of old ingredients and clinical trial failures in Phase 3 have required new emphasis on "doing it right, the first time." Better use of resources, carefully selected outsource partners and wise allocation of funding lead to fewer failed products in late stages and more success with the FDA review process.

In 2007 GZP added its first South African clients while dramatically increasing the number of Australian and US firms and programs that it represents to the FDA, for mid-discovery through full-scale clinical development and approval.

Several INDs that GZP created and submitted in 2006 received a...

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Source: Medical Letter on the CDC and FDA (2007-10-28)

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