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
USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
Swiss Medic: Guidance on Packaging for Human Medicinal Products
FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format
USFDA Guidance: Container Closure System and Component Changes: Glass Vials and Stoppers
Swissmedic Guidance: Electronic exchange of ICSRs through PV Gateway