Regulators are closely scrutinizing contract manufacturing organizations and active pharmaceutical ingredient suppliers, particularly in China and India. Enforcement against one of these partners can have disastrous consequences, including agency refusal to approve marketing applications for affected products. Assuring their compliance is therefore critical for protecting your product pipeline. —By Torrey Cope, Maurits J.F. Lugard and Chen Yang, Sidley Austin LLP Torrey Cope is a partner in Sidley's Washington, D.C, office. Maurits J.F.

Lugard leads Sidley's EU life sciences regulatory team and has nine years of regulatory and legal experience at the European Commission, advising on health and safety related trade barriers. He is based in Sidley's Brussels Office. Chen Yang is a partner in Sidley's Beijing office and leads Sidley's China life sciences practice. The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice. 3 .