These are the areas we work in. Each one is available as a consulting project or as a consultant on your team. What they have in common is that the experience only counts if it was earned inside a GxP-regulated company.
Designing, fixing, and running quality management systems. That includes CAPA, deviations, document control, and quality event workflows. A QMS can look fine in daily use and still fall apart when an investigator starts pulling records. Our consultants have kept quality systems running through audits and warning letter responses. Some have consent decree experience.
Learn more →Internal audits, supplier audits, mock inspections, and gap assessments for GMP, GLP, and device quality systems. We compare your quality system against what FDA and ICH expect, write findings you can act on, and follow the corrective actions until they are closed. We also do data integrity reviews and help during inspections and agency responses.
Learn more →The FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820) took effect February 2, 2026. It is built on ISO 13485:2016. We help device makers with QMSR gap assessments, design controls, complaint handling, CAPA, and post-market compliance. We also prepare companies for FDA, MDSAP, and notified body audits, and support EU MDR and IVDR work. Years under the old QSR do not guarantee someone knows ISO 13485 well, so we check.
Learn more →Computer System Validation and Computer Software Assurance under GAMP 5, 21 CFR Part 11, and EU Annex 11, including electronic records and audit trails. How much testing a system needs depends on its risk. Some call for traditional CSV protocols. Others fit FDA's CSA guidance better. Pharma, biotech, and device companies also apply these frameworks differently, so experience in one does not always carry over.
Learn more →Change control, remediation, and deviation resolution when the FDA is paying attention. Our consultants have worked on Form 483 responses, warning letter remediation, cleanup before an inspection, and consent decrees.
Learn more →Validation for SAP, Oracle, and similar enterprise systems, including SAP S/4HANA, SAP ECC, and SAP QM. We handle IQ/OQ/PQ documentation, coordinate change control, and keep production systems ready for inspection. When the system is upgraded or reconfigured, we keep it in a validated state.
Learn more →Validation and lifecycle management for manufacturing execution systems and laboratory information management systems. Our consultants have worked with Werum PAS-X, DeltaV, LABVANTAGE, and similar platforms in pharma production and GLP labs.
Learn more →Interim QA and compliance directors, remediation program leaders, and validation project managers. A good general project manager can keep a schedule. In a GxP program they also need to know which validation steps depend on which, how to get QA, IT, and operations moving together, and what happens when a date promised to the FDA slips.
Learn more →Share your situation and the systems involved, and we will outline how we would approach it.