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
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
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: Control of Nitrosamine Impurities in Human Drugs
USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway
India's: Newly Launched Indian Pharmacopoeia (IP) Online Portal and Adverse Drug Monitoring System (ADRMS) Online Portal
UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway
India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)
UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support