Our Specialisations
Validation compliance & Specialized Staffing
Our validation and compliance consultancies are supported by specialized staffing models and supporting IT solutions.
GxP & CSV
GxP Validation & CSV/CSA Compliance
GxP-compliant engineering, Computer Systems Validation (CSV), Computer Software Assurance (CSA), and computerized data integrity checks.
- CSV & CSA Validation: Master plans, gap assessments, IQ/OQ/PQ protocols, and validation lifecycle support.
- Validated Environment Controls: System diagnostics, automated audits, and change control checks to keep software compliant.
- Inspection Readiness & Audits: Pre-inspection assessments, regulatory alignment gaps, and data integrity audits (ALCOA+).
- SOPs & Regulatory Support: Standard Operating Procedure (SOP) design, compliance manuals, and validation lead training workshops.
Enterprise IT Services
IT Services
Custom software development, cloud infrastructure management, secure database pipelines, and seamless compliance integrations for enterprise & regulated environments.
- Validated Cloud Setup: Compliant AWS/Azure/GCP environment design conforming to regulatory requirements.
- Systems Integration: Secure connections for clinical portals, custom databases, and LIMS.
- Compliance Tooling: Custom logging algorithms and automated testing platforms.
- Cybersecurity Audits: Threat analysis, database sandboxing, and secure OAuth2 compliance protocols.
Global Staffing
Global Staffing Solutions
On-demand contract staffing of CSV engineers, validation leads, QA compliance testers, and GxP regulatory consultants to keep your validation cycles on track.
- Rapid Sourcing: Deploy validation experts from our pre-vetted domain pool within 72 hours.
- Cost Efficiency: Lower onboarding overheads and pay only for validation project durations.
- Domain Specialists: Vetted CSV contractors experienced in drafting and executing IQ/OQ/PQ protocols.
- Full Handoff Support: We manage compliance, onboarding, and payroll details for smooth integration.