Empowering Healthcare Innovation Through Regulatory Excellence
Navigate global regulatory landscapes with confidence. Expert guidance for FDA 510(k), CE Mark (MDR/IVDR), and CDSCO approvals.
🎯 98% Client Satisfaction Rate
Join 50+ companies we've helped achieve regulatory approval
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Track record of excellence
Successful Approvals
FDA, CE Mark, and CDSCO
Global Markets
US, EU, and India
Expert Team
Seasoned professionals
Comprehensive Regulatory Solutions
End-to-end consulting services
Medical Device & Diagnostics
Complete regulatory support from FDA 510(k) submissions to CE Mark certifications.
- FDA 510(k) & PMA Submissions
- CE Mark (MDR/IVDR) Registration
- CDSCO Approval (India)
- ISO 13485 Implementation
- Clinical Evaluation Reports
Pharmaceuticals
Strategic regulatory affairs for drug development and approval.
- Drug Registration & Licensing
- Clinical Trial Authorization
- Pharmacovigilance Services
- GMP Compliance
- Regulatory Intelligence
Staffing & Recruiting
Connect with top regulatory talent across healthcare sectors.
- Regulatory Affairs Specialists
- Quality Assurance Professionals
- Clinical Research Associates
- Medical Writers
- Compliance Officers
About Yuhitech Consultancy Services
Your Trusted Partner in Global Regulatory Compliance
Founded in 2025, Yuhitech Consultancy Services Pvt. Ltd. is an emerging leader in global regulatory compliance for medical devices, pharmaceuticals, and biologics.
Our team combines deep engineering expertise with comprehensive regulatory knowledge, serving clients across the United States, European Union, India, and international markets.
Mission-Driven
Making an impact for clients, people, and society
Global Reach
Offices in Noida & Delhi, serving worldwide
Our Core Values
The principles that guide everything we do
Integrity
Honest, transparent, and committed to doing what's right.
Accountability
Taking ownership and delivering on commitments.
Performance
Consistently delivering excellence.
Respect
Valuing every team member and collaboration.
Entrepreneurial Spirit
Think big, act fast, deliver with agility.
What Our Clients Say
Trusted by leading companies worldwide
"Yuhitech's expertise in navigating the FDA 510(k) process was exceptional. They helped us secure approval 3 months ahead of schedule. Their attention to detail and proactive communication made the entire process seamless. Highly recommended for any medical device company seeking US market entry."
"The transition from MDD to MDR was daunting, but Yuhitech guided us through every step. Their deep understanding of EU regulations and ability to translate complex requirements into actionable steps was invaluable. We achieved CE Mark certification without any major delays."
"Working with Yuhitech for our CDSCO drug registration was a game-changer. Their team's knowledge of Indian regulatory landscape and established relationships with authorities expedited our approval process. Professional, responsive, and results-driven."
Ready to Navigate Your Regulatory Journey?
Schedule a free consultation with our experts today