Swissmedic Guidance: Requesting Certificate of a Pharmaceutical Product (CPP)
Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
Philippines FDA: Guidelines on Regulatory Reliance on the Conduct of Clinical Trials
Swiss Medic Guidance: Product Information & Packaging for Human Medicinal Products
USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens
ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
EMA Procedural Advice: Recommendations on Unforeseen Variations
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
Swiss Medic Guidance: Document on Formal requirements
EMA Checklist: Updated Validation checklist for Type II quality variations
Pakistan DRAP Guidance: GMP for Manufacturing Sites of Drugs
South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products
Ireland's HPRA: Guide to Clinical Trial Applications
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products
MHRA Guidance: Innovative Licensing and Access Pathway (updation)
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form