2104 Results for "Marlian 200-205.pdf":

Change of Delegated Sponsor Activities

FDA sponsor and CRO form for change of delegated sponsor activities

Change of Qualified Person

FDA sponsor and CRO form for change of qualified person

Clinical Trial Registration and Application Form

FDA form for clinical trial registration and application

Clinical Trial Protocol Amendment

FDA protocol for clinical trial amendment

Permit to Import Clinical Trial Materials

FDA list of requirements for permit to import clinical trial materials

Assessment Slip

FDA assessment slip

Annex B Request for GMP Evidence Evaluation Form

FDA request form for GMP evidence evaluation

Annex D Application Form for Foreign Manufacturing GMP Inspection

FDA application form for foreign manufacturing GMP inspection

Annex E Affidavit of Undertaking

FDA affidavit of undertaking for Foreign Good Manufacturing Practice

List of Requirements for Foreign GMP Clearance

FDA list of requirements for foreign GMP clearance