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Search for "fda"

Displaying results 1 to 6 out of 6

  Consultancy 81%
  ... extensive experience with the European Medicines Agency (EMA) and national European regulators as well as the US Food & Drug Administration (FDA). CRS's services include: Setting up clinical study protocols and clinical development plans both in early and late-stage development ...
  Size: 30 K - Created: 18-11-12 - Modified: 20-06-17 17:09
Path: /Services/Consultancy

  Mailing Campaign (Kopie Home) 77%
  ... sample processing Large clinical capacities - 6 clinical units with over 275 beds in Germany High quality - multiple authority inspections (FDA, EMA, BfArM, AFSSAPS, ANVISA, DHMA, etc.) Broad panel of subjects - access to patients, special populations and healthy volunteers      ...
  Size: 33 K - Created: 11-01-17 - Modified: 20-06-17 17:09
Path: /Home/Mailing Campaign (Kopie Home)

  QA & QC 72%
  ... providers  Preparing inspections by sponsors and regulatory authorities; representing CRS vis-à-vis external organisations including the FDA, sponsors and other organisations; serving as a primary contact during all audits and generating responses to audit reports. Carried out ...
  Size: 31 K - Created: 18-11-12 - Modified: 20-06-17 17:09
Path: /Services/QA & QC

  Kiel 69%
  ... special patient population studies (e.g. renal/hepatic impairment trials). In 2000, the unit joined the IKP Group and successfully passed FDA inspection in 2002. Since January 2007, it has operated as CRS-Kiel, a member of CRS.
  Size: 32 K - Created: 18-11-12 - Modified: 20-06-17 17:09
Path: /Locations/Kiel

  Trial Expertise 63%
  ... and biosimilars and all modes of administration such as oral, transdermal, buccal and sublingual. In 2008, 2009, 2010, 2011 and 2014, the FDA performed inspections of bioequivalence studies and awarded the highest rating in all cases: ‘No Action Indicated’. Food-drug interaction ...
  Size: 35 K - Created: 18-11-12 - Modified: 20-06-17 17:09
Path: /Expertise/Trial Expertise

  1990 – 1999 47%
  ... and Omeprazole. Poster, 1. United European Gastroenterology Week, Athens 1992 Theiß U . GCP in Phase I – Trials- Experiences During a FDA Audit, Lecture, 14. Bobenheimer Allerheiligengespräch, October 1992 Theiß, U. , Wieckhorst, G., Hartmann, M., Lühmann, R., Huber, R., Bliesath, ...
  Size: 61 K - Created: 18-11-12 - Modified: 20-06-17 17:09
Path: /Expertise/Published Expertise/1990 – 1999

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