Operon Strategist
Exhibitors
Information
Operon Strategist Service Portfolio
Turnkey Projects | Manufacturing Site Conceptualization
Facility layout Design as per cGMP norms | Regulatory Aspects of Clean Room & Validation
QMS and Certification
21 CFR 820 | ISO 13485 | ISO 15378 | MDSAP
Regulatory approvals
CDSCO | USFDA 510k | CE (EU MDR) | UKCA | SFDA
Regulatory consultancy for Design and Development
Medical Devices | Drug-Device Combination Product
Primary packaging Turnkey project
CDSCO / Indian FDA Consulting
