Full-stack regulatory under one roof
Six dedicated practices — pick what you need, or engage us end-to-end from idea to post-market.
Regulatory Compliance
End-to-end CDSCO licensing, Legal Metrology, and EPR — assembled by senior regulatory experts so you launch with confidence.
Clinical Studies & PER
Protocol design, IRB liaison, site selection, monitoring, and PER preparation — managed by clinical specialists with deep bioethics expertise.
Certifications & Quality
ISO 13485 QMS, CE Mark / MDR, BIS, FDA QSR, and GMP — implementation, internal audit, and certification body liaison under one roof.
Performance Evaluation (IVD)
Analytical and clinical performance evaluation for IVDs — design, execution, and submission-ready PER compilation.
Manufacturing & Turnkey
Site selection, GMP-compliant facility design, equipment qualification, validation, and tech transfer — built and handed over ready to operate.
Market Access & Launch
Pricing, distribution, state-level licensing, tender / GeM portal navigation, and channel partner onboarding — turn approval into revenue.
License Holder Services
CDSCO-recognized representation for foreign manufacturers. We hold your import license, manage vigilance, and handle every regulatory touchpoint while you focus on the device.
Joint Venture
Partner-matching, contract structuring, and operational launch support for foreign manufacturers entering India through joint ventures.
DPIIT / EPR
DPIIT recognition, EPR registration, e-waste management plans, and annual return filing — fully managed compliance for medical device importers and manufacturers.
GeM Portal
GeM portal registration, OEM panel approval, product cataloguing, and tender response support — for medical device companies serving the government healthcare market.
Contract Manufacturing
Contract manufacturing operations for medical devices and IVDs — design transfer, GMP-compliant production, quality release, and lifecycle support.