T-Regs Consulting Ltd provides specialist laboratory informatics, computerised system validation (CSV) and GxP compliance consultancy to the pharmaceutical and life sciences industries, together with project leadership for digital laboratory transformation programmes. Founded in 2019 by Jay Kissinger, a laboratory scientist and former GLP Study Director, the consultancy combines scientific, technical and practical delivery expertise.

We support LIMS, ELN, SDMS and related systems throughout their lifecycle, from business analysis and requirements through design, implementation and validation to upgrades, support and retirement. Our work also covers data integrity assessment and remediation, stakeholder engagement and supplier coordination. We have particular expertise in Waters NuGenesis SDMS and LMS, including administration, upgrades, data migration and bespoke Smart Builder development.

Applying GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and data integrity principles, we take a risk-based approach within clients’ quality management systems and produce clear documentation that will withstand regulatory scrutiny. Our aim is to facilitate solutions that are fit for purpose and meet the needs of laboratory, IT, quality and business functions alike.

Whether providing specialist technical input, independent project leadership or support with a broader laboratory transformation, we work collaboratively and prioritise knowledge transfer, so that teams can maintain and build on the work after the engagement ends.