Australia TGA: Clinical Trial Notification (CTN) Form - User Guide
USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports
South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs
Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)
Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines
Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications
USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples
EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products
USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act
ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
UK MHRA: Guidance on Established Medicines Marketing Authorisation Application Process Changes
UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets
India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion
USFDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates