Regulatory Affairs

Medical device and drug manufacturers must maintain communication with global regulatory agencies in an ongoing effort to ensure regulatory compliance. Manufacturers must submit data on product registration, product variations, registration renewals, commitments, and distribution methods. It’s essential to maintain electronic records of global product portfolios with a single regulatory compliance management system.

Why Dot?

Best practices pre-configured workflow supporting product launch, registration plan, master state registration, variations, renewals, correspondence and commitments management.

FDA and EMA registration procedure support (CP/DCP/MRP registration).

CE Registration

Multilingual support

Reports and KPIs

Reports and KPIs

User-friendly product

"  The product is user friendly. The flows in the system are the best practices that are used in the pharmaceutical industry (21 CFR Part 11, Annex 11, GAMP 5). Almost no adjustments (customizations) are needed. The validation package is very thorough and comprehensive. The software is stable almost without faults."

Computerized Systems Validation in Pharmaceutical 

Bella B.

 Good value for money

"    The overall experience is good, the company uses the system as part of our routine and it has become part of our DNA. we get good support when needed, numerous aspects of the QMS are captured in one system - easiness of use - easy communication with other company employees "

Yoel B.

Avoid lengthy design and configuration processes with our core QMS processes

Dot Compliance is the leading 

ready-to-use Quality Management Software

Start streamlining regulatory affairs in a matter of days

A simple, powerful and affordable way to manage your quality processes.