Services we offer
GMP Audits; Quality Systems; Manufacturing; Lab and Analytical Methods; Remediations- 483s and Health Canada Observations
Gap Analysis and Remediation; Deviations and Incidents; Failure Investigation; CAPAs; Complaint Handling and Recall
CMC Change Management; Batch Production Records; QA Release; SOPs and Documentation; ISO 13485 and ISO 9001; Risk Assessment
Inspection Readiness; Validation
We prepare strategy include: Audit; Development of Validation Master Plan (VMP); IQ, OQ and PQ Execution; Protocol and Reporting; Development of internal auditing system with respect to Validation services.
CSV Strategy - strategy tailored to your processes, organisation and IT and automation landscape with equal focus on cost factor. This risk based approach will help you to carry out validation projects faster and with significantly lower outlay.
CSV Implementation - Our consultants will support your validation projects in a variety of roles e.g. Project MAnager, Validation engineer, Complaince Auditor.