We audit GMP, GLP, and device quality systems: your own, your suppliers', and yours again in a mock inspection. We compare what we find against FDA and ICH expectations, write findings you can act on, and follow the corrective actions until they are closed.
Scheduled audits of your own quality system and of the suppliers, CMOs, and CDMOs you rely on.
A practice inspection run the way an FDA investigator would run it. It is better to find the weak spots this way than during the real thing.
A line-by-line comparison of your procedures and practices against FDA and ICH expectations. For device makers, this includes QMSR gap assessments.
We look at records, systems, and audit trails for the data integrity problems investigators most often cite.
Help getting ready for an inspection and answering observations afterward.
A biotech is facing its first pre-approval inspection. It needs a mock inspection, a review of its documentation, and confidence that its electronic records will hold up under Part 11 and Annex 11.
A company's supplier audit schedule has fallen behind. An audit specialist plans and conducts the audits and follows each finding until it is closed.
A device maker is closing gaps against the QMSR and ISO 13485. Its procedures, design controls, and CAPA process need work. If a new ERP or eQMS is part of the plan, it needs validation help too.
An audit program or gap assessment with an agreed scope and schedule. You get a written report at the end.
An audit specialist who joins your team to run or support your audit program.
Share your situation and the systems involved, and we will outline how we would approach it.