USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A
EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs
Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications
EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products
Ireland HPRA: Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
Australia TGA: Clinical Trial Notification (CTN) Form - User Guide
USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports
South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs
Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)
Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines
Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications
USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples
EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences