- 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.
We provide QMS consulting aligned with:
• ISO 13485 (Medical Devices)
• GMP requirements
• CDSCO compliance frameworks
• US FDA Quality System Regulations
• EU MDR Quality Requirements
Our services include:
• QMS design and implementation
• SOP development and document control systems
• Risk management integration
• Internal audit preparation
• Inspection readiness planning
Audit-ready systems. Globally aligned processes.
We conduct structured gap assessments against applicable regulatory requirements and international standards.
Our assessments cover:
• Quality system deficiencies
• Technical documentation gaps
• Labeling compliance risks
• Clinical and performance documentation review
• Regulatory pathway evaluation
Clear findings. Actionable recommendations. Controlled remediation.
We support preparation and review of:
• Technical files & design dossiers
• CTD / eCTD submissions
• Device master files
• Risk management files
• PMS & vigilance documentation
• Change control & variation management
We ensure documentation integrity throughout the product lifecycle — from development to post-market.
Strong quality systems reduce regulatory risk, prevent approval delays, and protect your brand reputation.With Syntiq Global, you gain structured compliance, global regulatory alignment, and long-term regulatory confidence.
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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