Gap Assessment & AMC Support
Regulatory compliance is an ongoing operational commitment. Our Annual Maintenance Contracts (AMC) support manufacturers with periodic gap assessments, standard operating procedure (SOP) revisions, pharmacovigilance reports, and post-market surveillance records. We keep your facility 100% inspection-ready for sudden SLA or CLA visits throughout the year.
Key Benefits
- Zero downtime or compliance suspensions during unannounced regulatory inspections
- Continuous monitoring and correction of system effectiveness
- Cost-effective outsourced compliance management by expert auditors
Recognized Standards
Our Methodology
Contract Scope
Define the periodic review cycles (e.g. quarterly or bi-annual reviews).
Gap Audit
Conduct site audits to assess production logs, cleanliness, and QMS updates.
Reporting & Correction
Highlight findings and implement corrective and preventive actions (CAPA).
Required Documents
Common Questions
Related Regulatory Insights
Navigating the New CDSCO Medical Device Regulations: A Definitive Compliance Guide
Understand the regulatory shift under India's Medical Device Rules (MDR) 2017, classification pathways, and MD-15 import licensing requirements for global manufacturers.
The MD-42 Trade License: Selling Medical Devices in India
A breakdown of the MD-42 wholesale registration requirements for distributors, importers, and traders operating in India.
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