Our Services

Comprehensive regulatory, quality & market access solutions tailored to your business needs.

Regulatory strategy, submission support and licensing across global markets.

Registration Certificate (Form 41), Import License (Form 10/10-A), Form 11 Test Licenses and wholesale distribution support.

Equipment Type Approval (ETA), Dealer Possession Licenses (DPL) and RF test compliance for connected devices.

Statutory Form A & Form B registration for ultrasound, imaging machines and diagnostic equipment in India.

Import Export Code (IEC) and Authorised Dealer (AD) Code registration across Indian customs ports.

ISO 13485, QMS development, internal audits, CAPA & compliance readiness.

Prepare your Quality Management System for global MDSAP audits.

End-to-end technical file writing (STED), risk management & compliance support.

Market entry strategy, pricing, reimbursement & post-market compliance.

Internal audits, supplier audits, compliance & regulatory intelligence.

Have a unique regulatory challenge?

Let's build the right solution for your product.