Documented controls
Defined procedures, records and responsibilities across the product lifecycle.
INSITU TECHNOLOGIES (PVT) LIMITED
Regulatory & Quality
A disciplined pathway toward compliant manufacturing and product quality systems.
CURRENT POSITION
Regulatory milestones are in progress.
InSitu Technologies (PVT) Limited is pursuing ISO 13485 certification and working toward a DRAP manufacturing license. These authorizations have not yet been obtained. The program is being advanced in coordination with relevant regulatory authorities.
Our FDA-aligned approach informs facility planning, documentation, process controls, risk management and product validation. “FDA-aligned” describes the development approach; it does not represent an approval or certification.
QUALITY SYSTEM PRIORITIES
Process validation
Evidence-based qualification of equipment, methods and manufacturing processes.
Continuous oversight
Training, supplier controls, traceability, corrective action and management review.