13+ years delivering rigorous GxP audits, Computer System Validation, and technical writing for global life science and technology companies.
End-to-end compliance and quality assurance solutions tailored to the life science and technology sectors.
Third-party, vendor, and data centre audits with deep expertise in IT GxP across GMP, GCP, and GLP frameworks.
Full CSV project management for laboratory systems, manufacturing processes, and data centres per GAMP 5 and 21 CFR Part 11.
Expert creation of SOPs, Work Instructions, compliance plans, and cybersecurity and IT infrastructure documentation.
In-depth advisory on Data Integrity, ALCOA+, and international regulatory frameworks. Full support during regulatory audits.
Seminars and workshops on GxP, CSV, Data Integrity, and GAMP-5. Pre-audit preparation and gap assessments.
Audit and validation of complex systems: PLC/SCADA, SAP/ERP, QMS, DMS, BMS, EMS, and serialization platforms.
Lead auditor across API manufacturing, injectable plants, R&D facilities, and formulation sites across India, UAE, Bangladesh, and Vietnam.
Liten Solutions is a specialist consultancy offering GxP audit, compliance, and quality assurance services to life science and technology organisations worldwide.
Led by an ASQ Certified Quality Auditor with over 13 years of hands-on experience, we bring deep technical knowledge and a pragmatic approach to every engagement — from first-time CSV projects to complex multi-site regulatory audits.
We have served more than 50 global companies across pharmaceutical manufacturing, biotech, medical devices, and technology sectors, delivering high-quality outcomes that stand up to the most rigorous regulatory scrutiny.
Whether you need a one-off audit, ongoing compliance support, or a CSV project partner — get in touch and we'll respond within one business day.