Australia TGA: eCTD AU Module 1 and Regional Information v3.2
USFDA Medical Device: Guidance on Dental Products (Dental Impression Materials, Dental Ceramics, Dental Cements and Air Powered Dental Handpieces and Air Motors)
UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence
Malaysia’s NPRA: Guidance for Bioequivalence Inspection
India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
USFDA Guidance: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
USFDA Med Dev Guidance: Biocompatibility Testing and Accreditation Scheme for Conformity Assessment (ASCA) Program
SFDA Guidance: Conducting Clinical Trials with Decentralized Elements & Integrating Randomized Controlled Trials
EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
USFDA Guidance: Amendments to Abbreviated New Drug Applications (ANDAs) Under GDUFA
USFDA Guidance: Appeal Options for Mammography Facilities
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
UK MHRA: Windsor Framework: Wholesalers & Manufacturers Guidance & Labelling and Packaging Requirements
South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs
USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide