- info@syntiqglobal.com
- Block no.15/61G , Ist Floor, Sri Andal Avenue. Coimbatore 641016
Sustainable market access requires structured systems, accurate documentation, and ongoing regulatory alignment.
At Syntiq Global, we design compliance frameworks that withstand audits, inspections, and global regulatory scrutiny.
We build systems — not just documents.
Regulatory approvals increasingly depend on robust clinical data, risk management, and scientific validation.
At Syntiq Global, we align clinical strategy with regulatory requirements to minimize delays and strengthen submission success.
Evidence-backed. Strategically structured.
We provide regulatory guidance for clinical studies across India and global markets:
• Clinical trial application preparation
• Regulatory submission support to CDSCO and global authorities
• Ethics committee documentation support
• Investigator documentation review
• Clinical protocol alignment with regulatory expectations
We ensure your clinical pathway supports market authorization.
For medical devices and IVDs, we assist with:
• Clinical evaluation report (CER) support
• Performance evaluation documentation
• Post-market clinical follow-up planning
• Risk-benefit analysis documentation
• Compliance alignment with EU MDR and CDSCO MDR 2017
Structured evidence. Regulatory-ready documentation.
We integrate clinical strategy with regulatory lifecycle planning:
• Risk management planning (ISO 14971 alignment)
• Post-market surveillance planning
• Vigilance reporting frameworks
• Global submission coordination
• Regulatory update monitoring
From development to commercialization, we support a compliant lifecycle approach.
Let’s design a clinical and regulatory pathway that strengthens approval outcomes.
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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