Built on Expertise, Driven by Purpose
Mesra Regulatory Consulting Sdn. Bhd. (trading under the name DuoGate), was founded with a mission to provide comprehensive regulatory solutions for the medical device and cosmetic industry in Malaysia.
DuoGate was founded with a clear vision: to simplify the complex world of medical device and cosmetics regulation for manufacturers, distributors, and healthcare innovators worldwide.
With a team of seasoned regulatory specialists and deep industry connections, we help our clients bring safe, effective medical products and cosmetics to market across multiple jurisdictions — efficiently, compliantly, and confidently.
From initial classification to post-market surveillance, we serve as more than just a service provider. We are a trusted partner committed to your long-term success in the global medical device industry.
Mission & Vision
Guided by clear principles that define how we work and what we strive to achieve every day.
Our Mission
To empower medical device and cosmetic manufacturers and distributors with reliable, expert-driven regulatory solutions that accelerate market access while ensuring full compliance, safety, and quality across every product lifecycle.
Our Vision
To be the most trusted regulatory partner in the global medical device and cosmetic industry — known for our integrity, expertise, and unwavering commitment to advancing healthcare innovation through compliant market access.
Our Core Values
Honest, transparent, and ethical in everything we do. We earn trust by always doing what's right for our clients and for patients’ safety.
Integrity
Honest, transparent, and ethical in everything we do. We earn trust by always doing what's right for our clients and for patient safety.
Expertise
Deep regulatory knowledge backed by years of experience across multiple jurisdictions, device categories, and regulatory frameworks.
Partnership
We don't just deliver services — we build long-term relationships, working alongside you through every stage of your regulatory journey.
Efficiency
Streamlined processes and proactive communication that reduce delays, minimize risks, and accelerate your time to market.
Quality
Rigorous attention to detail and adherence to the highest standards in every dossier, submission, and compliance activity.
Global Perspective
A worldwide outlook combined with deep local market knowledge to support your international expansion goals.
Certifications & Recognitions
Officially recognized and certified to deliver regulatory services at the highest professional standard.
GDPMD Certified
Quality Management System Certified
Licensed AR
Authorized Representative Status
Global Network
International Industry Partner
Let's work together on your regulatory journey
Whether you're entering a new market or expanding globally, our team is ready to support your success.
Get In Touch