Consulting Service
Regulatory Advisory (GxP & SaMD)
Deliver validated pharma and healthcare software with CSV/GAMP 5 practices, SaMD lifecycle rigor, and submission-ready documentation.
Services
- Computer System Validation (CSV) planning and GAMP 5-aligned documentation
- QMS integration with change control, traceability, and risk management (ISO 14971)
- SaMD classification, lifecycle governance, clinical evaluation inputs, and post-market surveillance
- HIPAA/PHI data protections and privacy-by-design for regulated workflows
- Technical documentation packages and inspection/submission readiness (e.g., FDA/EMA expectations)
Deliverables
Validation plans/protocols/reports (VP, URS, IQ/OQ/PQ), risk files, traceability matrices, DHF/technical documentation, and inspection coaching.