IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
SFDA Guide to Good Manufacturing Practice for Medicinal Products
ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation
USFDA's New WebPage: For Complex Generics
EMA Guidance: Prevention of Medicine Shortages in the EU
EMA: Plan for Digital Hub for the European Medicines Regulatory Network
USFDA: Revising the National Drug Code Format and Drug Label Barcode Requirements
USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
HPRA Guide to Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
TGA guidance on Testimonials & Endorsements in Advertising
Free eBook- CAPA in the Pharmaceutical and Biotech Industries
SAPHRA - Guideline on Availability of Medicines for Use in a Public Health Emergency (PHE)
USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling
Guide to Clinical Trials conducted under the CTR in Ireland
USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
SFDA's Product Classification Guidance
FDA Guidance:Providing Submissions in Electronic & Non-Elec Format—Promotional Labeling &Advertising
EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)