Service
Our Core Services
Empowering Compliance in the Life Sciences Industry.
AssureGxP offers end-to-end compliance services tailored for pharmaceutical, biotech, medical device, and contract research/manufacturing organizations. With over 15 years of industry expertise, we provide practical, audit-ready solutions.
1. Computerized System Validation (CSV)
End-to-end CSV for
- Enterprise Systems (ERP, LIMS, QMS, etc.)
- Manufacturing Equipment
- QC Instruments (HPLC, UV, etc.)
- Server Hardware & Network Infra
Services include
- URS, Risk Assessment, VMP, GxP Assessments
- Periodic Review and Re-validation support
- IQ, OQ, PQ protocols and executions (with vendor support)
2. GxP Gap Assessments
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Assessments of existing validation dossiers.
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Gap report with risk classification.
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Recommendations and remediation roadmap.
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Audit readiness preparations.
3. GxP Compliance Support
Design and establishment of Quality System
- Developing Quality System procedures
- Designing QMS templates/ formats
- Designing self-inspection checklists and schedules
SOP development and review
Data Integrity audits
ALCOA+ principles trainings and implementation
Conducting mock audits
4. Vendor Qualification & Audits
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Development of Vendor Management Program
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Management of Audit Schedules
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Audit planning, execution and reporting for API, excipient and packaging material vendors
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Follow-up on CAPAs
5. Regulatory & Technical Trainings
Equip your team with the skills to stay compliant.
Topics: CSV fundamentals, software assurance, audit readiness, 21 CFR Part 11, ALCOA+
Formats: Live virtual, onsite workshops, Train-the-Trainer
Get in Touch
Drop Us a Line.
Let’s Build Future Together.
