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✓ To become a global leader in healthcare consulting
✓ To provide pragmatic and innovative solutions (with risk mitigation plan) in drug development,
regulatory strategy and manufacturing/quality
✓ Integrity & Ethics
✓ Honest Communication
✓ Innovation
✓ Sense of Urgency
✓ Transparency
✓ Successful implementation fo remote audits amidst the COVID pandemic
✓ Multiple FDA scietific advices and INDs for Biologics/novel biologics/biosimilars/complex molecules
✓ Successful approval of sNDA
✓ End-to-end Program management of Phase I - III clinical trials both in healthy volunteers and patients
✓ Successful implementation fo remote audits amidst the COVID pandemic
✓ Multiple FDA scietific advices and INDs for Biologics/novel biologics/biosimilars/complex molecules
✓ Successful approval of sNDA
✓ End-to-end Program management of Phase I - III clinical trials both in healthy volunteers and patients
✓ Successful implementation fo remote audits amidst the COVID pandemic
✓ Multiple FDA scietific advices and INDs for Biologics/novel biologics/biosimilars/complex molecules
✓ Successful approval of sNDA
✓ End-to-end Program management of Phase I - III clinical trials both in healthy volunteers and patients
✓ Completed 100+ cGMP audits of manufacturing sites for Client