Regulatory Services

Accelerating Innovation through compliance Navigating the regulatory landscape for medical technologies can be complex, but it doesn’t have to be. Our Regulatory Affairs team provides end-to-end guidance to help innovators, industries, and researchers bring safe, effective, and compliant medical devices to market faster.

Regulatory Strategy Development

We design customized regulatory pathways that align with your technology’s stage and market goals.

Gap Assessment & Standards Mapping
Device Classification & Predicate Identification
Regulatory Requirement Mapping (IMDR 2017 & Global Frameworks)
Regulatory Roadmap Development
CDSCO Portal Registration

Our team assists in registration with online system for medical devices and National Single Window System (NSWS) for all the reglatory submissions.

Licensing & Approvals

From prototype testing to full-scale commercialization, we streamline the licensing process through:

• Test License Applications
• Clinical Investigation Licenses
• Clinical Performance Evaluation Licenses
• Manufacturing Licenses
• Non-Notified device registration
• Sale Licenses

Why Choose Us?

We combine scientific expertise with regulatory insight to deliver strategic, time-saving solutions.

Tailored support for startups, technology partners, and academic innovators
Reduced approval timelines through optimized documentation
Guidance rooted in real-world regulatory experience

We help you move from concept to compliance ensuring your innovation reaches patients safely and efficiently

Partner With Us

Whether you’re developing a cutting-edge diagnostic, a novel medical device, or translational research ready for validation, our regulatory experts are here to support every step.

Let’s turn innovation into impact responsibly, efficiently, and compliantly