About Us

Who we are?

Regulatory made easy

A Germany based start-up with focus on regulatory affairs for Medical devices and In-Vitro Diagnostics. We focus on delivering quality work and build long term relationships with our valued partners.

OUR VISION & MISSION

To bring safe medical products to the market.

We are a one stop shop to bring compliant products to the end user. We support our valued partners with tailored regulatory strategies. We treat start-ups and large corporations with the same respect and diligence.

Care
Commit
Deliver

WE’LL ENSURE YOU ALWAYS GET BEST RESULTS.

10 + Years

Experience

Experience in research, quality and regulatory affairs

50 + Countries

Registration and renewal

Vast experience in product registration / renewal worldwide

45 +

Projects handled

Variety of projects handled ranging from development to final product

Founder, CEO, Regulatory enthusiast

Akanksha Nagpal

Passionate regulatory affairs professional with scientific knowledge and industry experience contributing to registration, renewal and post market surveillance in international markets.

Knowledge of FDA 510(k), Canada, Latin America, Asia-Pacific and EU regulations in Medical Devices and In-vitro Diagnostics (IVDR), certified by RAPS (RAC-EU) and TÜV Süd.