Regulatory Services:
– Due Diligence and Strategy
– Gap Analysis
– Compilation of Dossier M1-M5
– e CTD/NeeS Publication
– Readability test and Bridging reports
– Product information Texts
– Deficiency/Queries Management
– Life cycle management
Quality Management Services:
– Inspections support
– System analysis and troubleshooting
– Training system set up
– Deviation management
– Change control support
– CAPA Support
– SOP Support
– Supplier qualification support
Audit support:
– Internal audits
– Routine Internal audits
– Document audits
– External audits
Pharmacovogilance:
– Provision of QPPVx24/7
– ICSRs Support
– Safety Reporting
– Literature search
– SOP support
– PSMF support
– PSURs Preparation
– PhV Inspections support
– Risk Management Plan
– XEVMPD databases Handling
– Agency Audits and inspections.
– PV Training
– Data Entry
Medical Affairs/Clinical Writing:
– Expert Reports
– Risk Management Plan (RMP)
– Aggregate Reports (PSUR, ACO)
– Literature research
– Preparation of medical texts
– Medical enquiries Response
– Medical/scientific information support
– Product information Creation
Clinical support services:
– Medical writing
– Study Design & Planning
– Protocol, eCRF/CRF & ICF Development
– Site Selection & Feasibility
– Regulatory Strategy & Consulting
– Project & Site Management
– Site Monitoring
– GCP Site Audits
– Site preparation for Inspections
– On-Site Study Coordination
– Drug Safety & Pharmacovigilance Support
Pharmaceutical Translation:
– High quality Medical translation
– Proofreading for quality control
– Standard update for Pharmaceutical texts