USFDA Guidances: Topical Generic Drug Products - ANDAs
UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products
USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA
USFDA Guidance: Comparability Protocols for Postapproval Changes to CMC in an NDA, ANDA, or BLA
EMA Guidance: Scientific Advice and Protocol Assistance
UK MHRA Guidance: How to get a Parallel Import Licence in UK
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
MHRA Guidance: Export Drugs & Medicine, Active substances Manufactured in GB for use in EEA & NI
Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev
Philippines FDA: Guidelines on the Unified Licensing Requirements
USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances
SAPHRA (ECTD & Human Medicines Unit): Variation Communication Guideline
USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA
USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules
Swissmedic Guidance: Medicinal Product Name HMV4
Canada Guidance: Regulatory Enrolment Process (REP)
EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP
UK MHRA: European Commission Decision Reliance Procedure (EC DRP) Extension
EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources
MHRA Guidance: Good Clinical Practice for Clinical Trials