To establish documented evidence that provides a high degree of assurance that computerized systems which could have an impact on product quality (e.g. ERP, DCS, PCS, LIMS, Excel Spread Sheets) will consistently perform as intended in their operational environment according to predetermined specificat...
financial statements and the group management report for the business year from October 1, 2004 to September 30, 2005 satisfy the conditions required for the Company's exemption from its duty to prepare consolidated financial statements and the group management report in accordance with German law. ...
Table2:LawsandregulatorypathwaysfordrugapprovalintheUS Law/ApplicationSmall-moleculedrugBiologics LawFood,DrugandCosmeticAct(FD&C)PublicHealthServiceAct(PHS) DrugapplicationNewDrugApplication(NDA)BiologicLicenseApplication(BLA) Genericapplication AbbreviatedNewDrugApplication (ANDA) Nopathwayyet ComparisonpropertySmall...
This study evaluates the degree to which up-to- date bathymetry is required for accurate coastal erosion predictions using the morphodynamic model XBeach and, subsequently, whether a range of "representative" and/or "synthetic" bathymetries can be used for the bottom boundary, when a survey of ...
Table2:LawsandregulatorypathwaysfordrugapprovalintheUS Law/ApplicationSmall-moleculedrugBiologics LawFood,DrugandCosmeticAct(FD&C)PublicHealthServiceAct(PHS) DrugapplicationNewDrugApplication(NDA)BiologicLicenseApplication(BLA) Genericapplication AbbreviatedNewDrugApplication (ANDA) Nopathwayyet ComparisonpropertySmall...