We work with companies that make drugs, biologics, therapies, and medical devices. In all of them, a quality failure can end up affecting a patient. That is the common thread.
Drug manufacturers working under 21 CFR Parts 210/211. Quality systems, lab systems, and ERP platforms all need solid IQ/OQ/PQ documentation, reliable audit trails, and disciplined change control. An investigator can ask to see any of it.
Biologics and biosimilar manufacturers, where batch records, manufacturing execution, and quality events all run through validated systems. The hardest stretch is usually the move from clinical to commercial production. Processes have to scale, and FDA starts looking much more closely.
Cell and gene therapy developers moving toward commercial manufacturing. Many of these processes are patient-specific. With an autologous therapy, the material that leaves the patient has to come back to the same patient, and the quality system has to prove it did. FDA guidance in this area is also still changing.
Class II and Class III device makers working under the FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820). It took effect February 2, 2026 and incorporates ISO 13485. The work includes QMSR gap assessments, design controls, complaint handling, CAPA, and process validation. Companies selling in Europe also have EU MDR and IVDR to meet.
A CDMO has to meet its own GMP obligations and the separate expectations of each client, often on the same equipment and systems. Each client has its own quality agreement. A change to a shared system can affect all of them, so validation gets complicated quickly.
Companies working under GMP, GLP, or GCP, where validated systems hold the data that regulators rely on. The people doing this work need to understand both the GxP rules and the systems that support them.
Large molecule biologics and vaccine manufacturers. Lot release, batch records, and the data behind regulatory submissions all depend on validated systems. Cold chain traceability and sterility assurance add requirements that small molecule plants do not face.
Sterile injectables, oncology products, and OTC manufacturers. The riskier the product, the more validation it needs. Sterile sites in particular depend on validated systems for environmental monitoring, cleanroom controls, and aseptic process records.
QC and analytical labs that support pharma and biotech manufacturing. LIMS, chromatography data systems, and quality platforms all have to be validated under GLP and GMP. Data integrity findings show up in labs more than almost anywhere else, so audit trails and instrument qualification get a lot of attention.
We only work with pharmaceutical, biotech, and medical device companies and the CDMOs and CMOs that serve them. When we have grown, it has been by taking on more kinds of quality and compliance work in this sector. We have not moved into other industries. Staying here is how we have learned the differences between a validation role at a CDMO and one at a device maker.
What do you make, what systems are involved, and what is the problem? We will tell you how we would approach it.