REGULATORY LICENSING & GLOBAL APPROVALS

From India to International Markets — We Secure Your Regulatory Pathway. We provide end-to-end regulatory licensing and approval support across India and major global markets including US FDA, EU MDR, MHRA (UK), TGA (Australia), Health Canada, and other regulatory authorities.

Regulatory Compliance Is Global — Your Strategy Should Be Too.

Each country has unique regulatory requirements, submission formats, and review expectations. At Syntiq Global, we design structured, market-specific regulatory strategies to accelerate approvals while ensuring long-term compliance. We don’t just prepare submissions — we build global regulatory roadmaps.

OUR GLOBAL LICENSING SERVICES

Pharmaceutical & Biologics Licensing

Market authorizations, import/export licenses, drug registrations, CTD/eCTD dossier preparation, renewals, and post-approval variations across India, US, EU, UK, Canada, and other jurisdictions.

Medical Device & IVD Regulatory Approvals

CDSCO registration (MDR 2017), US FDA 510(k)/De Novo support, EU MDR CE Marking documentation, UKCA support, and international regulatory submissions.

Nutraceutical & Food Compliance

FSSAI licensing, international food compliance support, labeling review, and regulatory classification guidance.

Cosmetic Product Approvals

India import registration, EU cosmetic compliance documentation, ingredient review, and regulatory safety documentation support. Structured submissions. Market-ready compliance.

GLOBAL COMPLIANCE & DOCUMENTATION SUPPORT

Global approvals demand strong documentation and harmonized systems. We provide:

• Gap assessments aligned with regional regulations
• CTD / eCTD dossier preparation
• Technical File & Design Dossier support
• ISO 13485 & QMS consulting
• Labeling and artwork compliance review
• Post-approval change & lifecycle management

Inspection-ready systems aligned with international standards.

CLINICAL & REGULATORY STRATEGY SUPPORT

We guide clients through complex clinical and regulatory pathways globally:

• Clinical trial regulatory planning
• Performance evaluation documentation for IVDs
• Risk management and regulatory strategy development
• Global submission coordination
• Post-market regulatory compliance

From development to commercialization, we align science with regulatory expectations.

Planning to Enter India or Expand Globally?

Let’s design a regulatory strategy that supports both compliance and commercial growth.

Get in Touch

Consultation Request

Have a regulatory challenge or project in mind?
Share your requirements and our team will respond promptly.

Let's Talk

Phone : +919629542753
Phone : +918903282797

Mail Us

info@syntiqglobal.com

REGULATORY LICENSING & GLOBAL APPROVALS

From India to International Markets — We Secure Your Regulatory Pathway. We provide end-to-end regulatory licensing and approval support across India and major global markets including US FDA, EU MDR, MHRA (UK), TGA (Australia), Health Canada, and other regulatory authorities.

OUR GLOBAL LICENSING SERVICES

Planning to Enter India or Expand Globally?

Get in Touch

Consultation Request

Get in touch

Services

Quick Links

Company