UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets
India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion
USFDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance
EMA: QRD updation and Product-Information Templates Updation
UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine
South Africe SAPHRA: Guidelines For Medicine Recalls – Withdrawals And Rapid Alerts
EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
USFDA CMC Guidance: Advanced Manufacturing Technologies Designation Program
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"
Saudi's SFDA: Good Manufacturing Practice for Blood Establishments
Australia TGA: eCTD AU module 1 and regional information
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers