We design, fix, and help run quality management systems for GxP-regulated companies. A QMS can look fine in daily use and still come apart when an investigator starts pulling CAPA records. We build CAPA, deviation, and document control processes that hold up when that happens.
We compare your QMS against what FDA and ICH expect. Then we write or rework the procedures and records where it falls short.
Investigations that find the real root cause, corrective actions that address it, and effectiveness checks that show whether they worked.
Deviations, nonconformances, and complaints that get assessed for risk and closed on time instead of piling up.
Procedures and records that are current, approved, and easy to find when an investigator asks for them.
Keeping the QMS running through audits and warning letter responses. Some of our consultants have also worked under consent decrees.
A CDMO is adding clients faster than its quality system can absorb them. It needs a contract Quality Systems Manager who has run a multi-client GMP operation.
A biotech is moving from clinical to commercial manufacturing. It needs a validation lead who has worked in biologics GMP production before.
A drug manufacturer has received a warning letter and committed to a remediation schedule. It needs a compliance lead and a CSV specialist to meet those dates.
A defined quality systems project with milestones. Examples are a QMS assessment, a CAPA overhaul, or a new document control system.
A quality systems manager or consultant who joins your team for a project or an interim role.
Share your situation and the systems involved, and we will outline how we would approach it.