Certified manufacturers
ISO 13485 or GMP sites preparing for surveillance audits.
Surveillance · ISO
Audit · Training
Training, Audit Support & Post-Approval Maintenance
Stay audit-ready after certification or licensing — NQSC supports internal audits, CAPA, training, and post-approval change control.
- 25+Years Experience
- 500+Companies
- Audit Support
- CAPA · Training
Audit & maintenance pathway
- 1Schedule internal audit programme
- 2Review open CAPA and deviations
- 3Update management review inputs
- 4Plan regulatory training cycles
AuditCAPATrainingRenewalMaintenance
Who needs this
Teams we support on this pathway
Share your situation. NQSC helps identify the right license type and documentation scope.
Licensed CDSCO sites
Post-approval change reporting and inspection readiness.
CDSCO · Change control
Quality teams needing capacity
Lean QA teams needing external audit and CAPA support.
CAPA · QA
Training programme owners
HR/QA leads building regulatory and GMP training calendars.
Training · SOP
Documentation
Documents & requirements checklist
Grouped for a quick readiness review before CDSCO Sugam filing.
Audit Programme
- Annual internal audit schedule
- Audit checklists by process area
- Previous audit findings log
- Corrective action tracking sheet
CAPA & MR
- CAPA procedure and forms
- Root cause analysis templates
- Management review agenda and minutes
- KPI and quality objective records
Training
- Training matrix by role
- GMP / ISO / regulatory curricula
- Attendance and competency records
- SOP change notification process
Process
How NQSC works on this service
A structured pathway from assessment to authority coordination.
Step 1
Assess
Review device class, site readiness, and the correct regulatory pathway.
Step 2
Document
Structure technical files, forms, and supporting evidence for submission.
Step 3
Submit
Coordinate portal filing, fees, and annexures with your authorized team.
Step 4
Coordinate
Support query responses and liaisoning with CDSCO and related authorities.
Step 5
Respond
Address clarifications, CAPA items, and supplementary documentation requests.
Step 6
Maintain
Track license conditions, renewals, and post-approval change reporting.
How NQSC helps
Documentation and coordination support
Support for documentation, portal coordination, and follow-up at every stage.
Expert guidance
Practical regulatory advice aligned to your device class and market stage.
Documentation support
Dossier preparation, checklists, and technical file structuring.
Portal coordination
Support for authority portals, query responses, and submission readiness.
Audit readiness
Gap reviews before inspections, audits, or notified-body assessments.
Follow-up support
Post-submission liaisoning, renewals, and change-control guidance.
Avoid delays
Common mistakes before filing
Issues NQSC often sees during readiness reviews before CDSCO filing.
CAPA without effectiveness checks
Actions closed without verifying recurrence prevention.
Audit findings repeated
Same observations in consecutive internal or external audits.
Training records incomplete
Staff performing tasks without documented competency.
Unreported post-approval changes
Design or process changes not notified to authorities.
Client trust
What clients say about NQSC support
Feedback from teams supported across certification, regulatory documentation, and compliance coordination.
“We are fully satisfied with the services provided by NQSC.”
“Excellent support throughout certification activities, including ISO, CE marking and CDSCO submissions.”
Selected clients supported by NQSC
FAQ
Questions before you apply
Short answers on forms, timelines, restrictions, and how NQSC supports your pathway.
NQSC supports internal audits and audit readiness. Certification audits are conducted by accredited bodies.
Yes. NQSC supports documentation retrieval, query preparation, and liaisoning during inspection windows.
Yes. NQSC provides tailored training on GMP, ISO 13485, CDSCO requirements, and audit best practices.
Ongoing change control, renewal planning, PMS, and audit cycles after initial license or certification.
Need audit or post-approval support?
Share your certification status and upcoming audit dates. NQSC will outline CAPA and readiness priorities.