|
ICON’S service portfolio includes but is not limited to NCEs,
biological/ biotechnological products, generics and biosimilars
(follow-on biologics), drug-device combination products and
medical devices, including clinical investigation submissions and
CE-marking expertise. |
|
ICON provides clients with scientific and technical regulatory affairs
expertise which covers the pharmaceutical drug or device product’s
life cycle from early strategic development through all phases of
clinical trial and marketing authorisation submissions. It also
provides comprehensive post-licensing support. |
|
ICON’s regulatory affairs expertise provides the crucial link between
the client, its products and regulatory authorities such as the
Medicines and Healthcare products Regulatory Agency (MHRA),
the European Medicines Agency (EMEA) and the US Food and Drug
Administration (FDA). |
|
ICON regulatory professionals have broad therapeutic knowledge
and experience with global regulatory procedures (Centralised,
Decentralised and Mutual Recognition procedures, MAAs and NDAs). |
|
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology
and medical device industries. We specialize in the strategic development, management and analysis
of programs that support clinical development–from compound selection to Phase I-IV clinical studies.
ICON currently has over 7,000 employees, operating from 68 locations in 38 countries.
Further information is available at www.iconplc.com |
