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This excerpt taken from the ELN 20-F filed Feb 26, 2009. Range of
Manufacturing Services
In addition to formulation development, EDT provides a range of
contract manufacturing services to include analytical
development, clinical trial manufacturing,
scale-up,
product registration support and supply chain management for
client products.
EDT offers our clients an extensive range of drug optimization
and development services including formulation development,
analytical development, clinical trial manufacturing and
scale-up and
product registration support. We provide full CMC (Chemistry,
Manufacturing and Controls section), support for the optimized
product, including handling responses to the relevant regulatory
agencies. Our extensive experience in handling the CMC sections
for clients provides our clients with valuable assistance in
dealing with regulatory agencies and also determining an
appropriate regulatory strategy for their products. The
co-habitation of development and manufacturing capabilities on
the same site allows for streamlined
scale-up and
transfer to commercial scale manufacturing activities.
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