Expert Regulatory and Quality Consulting
FDA, EU, Health Canada and More
Our Services
At MiQA & Regulatory, our consultants provide comprehensive support throughout the lifecycle of your Medical Devices, Pharmaceuticals, NHPs, Foods, and Cosmetics, from initiation to post-market phases
FDA 510(k), PMA , 513(g), Pre-Submission etc.
FDA Cybersecurity Documentation & Testing
Internal/External Audit Support
Health Canada & EU MDR
Clinical Strategy/Planning
Market Access – Middle East, Africa, South America, APAC
About Us
Your Trusted Partner in Regulatory and Quality Excellence.
Compliance Made Easy
Expertise & Guidance
With over 20 years of experience, our team of seasoned professionals, including ex-regulators and industry experts, provides tailored solutions for every stage of the product lifecycle
Market Readiness
Whether you’re a startup or multinational, we are committed to ensuring your product’s success in the global market while navigating the ever-evolving regulatory landscape.