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Regulatory Advice services

Regulatory Affairs: Malaysia vs India vs UK

 
 
SUBMISSIONS & APPROVALS MALAYSIA UK INDIA
Timelines 2 months 1-2 months 3 months
Electronic Submission × ×
Website Tracking × ×
Parallel Submission to Ethics Committee
DOCUMENTATION MALAYSIA UK INDIA
List / details / undertaking of the investigators
Synopsis of the Protocol
Affidavit in support of Investigator’s Brochure ×
Regulatory / IRB approvals of other countries
Pre-clinical data
Patent information (if applicable)
Dissolution/stability study data
Chemical information of the drug
Finance; facilities and staff relation information
 
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Phase 1 clinical trials,Phase I/IIa studies,ECG Studies
Clinical Trials, India,Indian CRO,Phase 1 clinical trials,Bioequivalence
 
 
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Ver. 1.76 (Last Updated - 30 June 2010)