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Clinical Safety Management:
Drug Safety & Reporting Training
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Signal & Risk Management:
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Signal Detection and Management
Development & Implementation
Adverse Event Intake
Local Pharmacovigilance
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REGULATORY AFFAIRS SERVICES
Regulatory Strategies Consulting
New Product Marketing Authorizations
Regulatory Gap Analysis & Remediation
Regulatory Due Diligence
API/DMF - Drug Safety
CMC Regulatory Advisory
ANDA & MA Holder
eCTD Publishing & Submission
Pharmaceutical Product labelling
GCP SERVICES
Audit
Clinical Trial Monitoring
Bioanalytical Monitoring
Bioequivalence Study monitoring
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Mr. Niranjan N Andhalkar
Director – Strategic Management & Planning
Dr. Sornaraja Thasma
Director – Business & Quality Assurance
