.

0 (hodnocen0 x )

EB

ONLINE

Hoboken, N.J. : John Wiley & Sons, c2011

1 online resource (ix, 284 p.) : ill

ISBN 9780470933503 (electronic bk.)

ISBN 9780470552353 (cloth)

ISBN 9780470933510

ISBN 9781118002278

Includes bibliographical references and index

Controlling regulatory costs -- Clear operation definitions of requirements -- Pre-regulatory audits -- Quality by design -- Outsourcing -- Electronic submissions -- Emea/fda coordination -- Managing FDA inspections -- Risk assessment -- Cases -- Cost containment analysis -- Managing regulation in times of chaos -- International regulation -- Cost contained regulatory compliance.

Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries

001728844

full

(Au-PeEL)EBL698933

(CaONFJC)MIL302560

(CaPaEBR)ebr10452136

(MiAaPQ)EBC698933

(OCoLC)706476143