Pharmaceutical
Bio Waiver Justifications & Well Established Use
Regulatory In-house Resource Services
eCTD Conversion & Submission
Safety Reporting & Submission
Risk Management & Signal Management
ICSR Processing & Literature Monitoring
Expert Regulatory Strategies
Health Care
Various Health Authorities Query Response
Post Approval Changes & Life Cycle Management
Real Time Regulatory Intelligence
New Product Authorizations
Regulatory & Medical Writing
Pharmacovigilance Services
Artwork Review & Compliance
Labelling Services
Regulatory Due Diligence
Patent Intelligence Support
Global CMC Advisory
Safety Writing
Clinical & Non-clinical Expert Reports
Gap Analysis & Remediation