Client: European medical device manufacturer specializing in insulin delivery systems. The Objective was aimed to enter the Indian market
with insulin pens and pen needles
Our Role:
Market Research & Feasibility:
• Conducted primary and secondary research on diabetes prevalence, treatment protocols, and device usage
• Assessed competitive landscape: BD, Novo Nordisk, Sanofi, and local players
• Identified regulatory requirements under CDSCO for Class B medical devices
Regulatory & Legal Setup:
• Incorporation of Subsidiary in India with all statutory certificates
• Recruitment of Key Staff in India Including Country Manager and Account Managers
• Registered products with CDSCO including Device Master File and Import License
Operational Support:
• Accounting and Booking Support, Payroll Management
• Tax and finance support services
• Company Law and FEMA Support
• Special Valuation Branch
Outcome:
• Moved from exploration to execution in under 15 months
• Fully compliant legal entity ready for operations
• Operational readiness with robust compliance systems
• Successful product launch with initial traction in Tier 1 cities
Impact:
• Accelerated Commercialization, Regulatory Success, Strategic Partnerships, Sustained Market Presence, Risk Mitigation and others