Standards
TGA Issues New Guidance for TGO 101 (Standard for Tablets, Capsules and Pills)
IMDRF Offers Final Clinical Guidelines
South Africa released Guidelines – How to Submit EOI to SAHPRA on WHO Collaborative Registration Procedure
USA: FDA Revises Guidance on Post marketing Studies and Clinical Trials
EU: EC Offers New Site Suitability Template under Incoming Clinical Trial Regulation
Regulatory CMC Changes – Challenges and Management
The First Step
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