RegKey is an AI-assisted and expert-curated regulatory intelligence platform that simplifies intricate regulatory tasks to empower pharmaceutical teams.


One-stop Hub

Consolidate all essential data and analysis within a single, powerful platform.


Expert curated AI

Engage with RegKey using natural language to access cutting-edge global regulatory intelligence, curated by SMEs, with direct access to industry leaders--all at your fingertips.


Streamline Workflow

Regkey guides you through regulatory planning, study design, and writing tasks. It tracks changes in guidance, competitor info, and more, delivering timely updates throughout the lifecycle.


Dynamic and Collaborative

Experience real-time collaboration, advanced file sharing, integrated task management, and robust security--designed to boost team productivity and communication.


Expert guidance a tap away

Regkey combines AI power with human expertise, connecting you directly with domain experts anytime, anywhere in your drug development journey.



Testimonials

"RegKey is a game-changer. This tool has greatly enhanced our efficiency and accuracy in navigating complex regulations. I highly recommend it for any organization focused on regulatory excellence."

Director, RA-CMC

"I am extremely impressed with RegKey for its precision and efficiency. It simplifies complex regulatory requirements. It can easily streamline our processes and reduced risk. I wholeheartedly recommend it for enhancing regulatory accuracy and efficiency."

Director, RA Lead

"I’ve found RegKey to be invaluable. It offers seamless integration in navigating regulatory requirements. The tool’s efficiency has streamlined our compliance efforts and improved our operational agility. I highly endorse it !!”

Senior Manager, Regulatory Affairs

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Person One

"Awesome, Super!"

Person Two

A platform for the whole team

Clinical

RegKey delivers global regulatory insights with natural language and voice navigation, offering real-time support throughout drug development and post-approval, streamlining regulatory preparation with ease and accuracy.

Commercial

RegKey empowers commercial teams with expert-curated competitive intelligence, and global guidance. Stay informed on the latest laws, drug labeling, and clinical trials to accelerate product launches and drive success.

CMC Regulatory

RegKey simplifies CMC regulatory tasks by providing insights into reporting standards, making it easier to manage production changes, maintain compliance, and ensure product quality, stability, and safety from production to distribution.

About Us

Aruna
Dontabhaktuni, PhD

Co-Founder, CEO

28 years in Pharma.

Somdip
Datta, PhD

Co-Founder, CTO

20 years in Fintech.

Bhaskar
Gandavabi

Co-Founder, COO

30 years in Technology.


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