- info@syntiqglobal.com
- Block no.15/61G , Ist Floor, Sri Andal Avenue. Coimbatore 641016
Foreign manufacturers entering India must appoint an Authorized Indian Agent under CDSCO regulations. Similarly, international markets often require local representatives or regulatory contact points. We provide structured, compliant, and technically competent regulatory representation.
We represent foreign manufacturers before CDSCO for:
• Drug import registration & licensing
• Medical device & IVD import approvals
• Regulatory query management
• Amendments, renewals, and variations
• Authority communications & inspections
We act as your legally responsible regulatory liaison in India.
For global markets, we provide regulatory coordination and strategic support for:
• US FDA submissions
• EU MDR CE documentation support
• UKCA coordination
• Health Canada regulatory alignment
• TGA compliance support
We ensure consistent documentation and harmonized regulatory strategy across regions.
Regulatory representation continues beyond approval.
We manage:
• License renewals
• Change notifications
• Safety & vigilance coordination
• Regulatory update monitoring
• Ongoing authority liaison
Long-term compliance. Sustained market access.
Let Syntiq Global represent your products with accountability, technical strength, and strategic clarity.
Have a regulatory challenge or project in mind?
Share your requirements and our team will respond promptly.
Phone : +919629542753 Phone : +918903282797
info@syntiqglobal.com
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