Swissmedic Guidance: Requesting Certificate of a Pharmaceutical Product (CPP)
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
Swiss Medic Guidance: Document on Formal requirements
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
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
Irelands HPRA's: Guide to Fees for Human Products
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program
USFDA: First Drug Approved by FDA to Delay Type 1 Diabetes Onset
SFDA Guidance: Conditional Approval for Medicinal Products for Human Use