Ethicare – headquartered in Ahmedabad, India – is a leading full-spectrum PV & CTM service provider. Ethicare provides quality-driven Service to Pharmaceutical, Biotech, Medical Devices and Nutraceutical Companies across the Globe. We provideend-to-end Pharmacovigilance Services in various stages of the product cycle which includes Clinical Trial Safety Management and Post Marketing Safety Management.
Ethicare team has expertise in Medical Information Call Centre, Global Literature Management, ICSR (Adverse Event) Processing & Submissions, Aggregate Reports (DSUR, PADER, PSUR, PBRER, ASR) preparation, Signal Management, Risk Management Plan (RMP), Risk Evaluation Mitigation Strategy (REMS), Safety Management Plan (SMP), Global / Country Specific Pharmacovigilance System Master File (PSMF/PvMF), QPPV/RPPV/PvOI Service, Compliance Management, Audi/Inspection Readiness & Support, PV System Set-up for MAH.Our tailor-made and cost-effective business models help to achieve maximum client satisfaction along with meeting technical compliance.
We have cleared 8 USFDA Inspections,2 Health Canada inspections,3 MoHKazakhstan Inspections,1 TGA (Australia), 2 CDSCO-PvPI (India), 1 EMA(European Union), 1 WHO inspectionand multiple client audits / third-party audits from the USA, UK, Europe, India, Canada, and ROW successfully. Offering services globally, with 60% international and 40% domestic coverage.
Ethicare’s skilled professionals operate nationally within India and internationally through collaborative approaches and will benefit the projects by applying high-level of expertise, state-of-the-art industry best practices and thorough knowledge of regulatory requirements.