Our Services
Quality & Compliance
The complete practice — the systems you build on, the controls that keep them honest, and the assurance that proves them — quality run as one operating system.
Our Services
The complete practice — the systems you build on, the controls that keep them honest, and the assurance that proves them — quality run as one operating system.
The practice
Compliance isn't a binder — it's how the organization operates every day. Below is the full practice across four layers: the foundation you build on, the controls that keep it in check, the assurance that proves it, and the specialized modalities.
The framework everything else stands on — the QMS, its documents, and the standards it answers to.
QMS ImplementationQuality systems sized to your stage and built to scale.
Design Controls & DHFDesign inputs, V&V, and a Design History File built to pass inspection.
Complaint Handling & MDRIntake to reportability to CAPA, on the MDR and vigilance clock.
SOPs & Document ControlProcedures people follow because they were written to be followed.
Change ControlEvery change assessed, justified, and closed on time.
ISO 13485 & 14971Certification-ready device QMS and risk files.
GxP ComplianceGMP, GLP, GCP, GDP, GVP: one coherent compliance posture.The mechanisms that keep the system honest as it runs — catching, containing, and validating change.
CAPA & RemediationRoot cause to closed loop, including after a 483.
Risk ManagementRisk files that drive decisions, not shelfware.
Data Integrity & Part 11ALCOA+ evidence for every record an inspector can pull.
Computer System ValidationCSV to CSA: validation scaled to actual risk.
Commissioning & QualificationDQ to PQ: facilities and utilities proven fit for use.
AI & ML ComplianceGovernance for models regulators are learning to inspect.
Digital TransformationPaper to platform without a compliance gap.The proof that the system works — before a regulator, a partner, or an acquirer asks for it.
Inspection ReadinessReady for the knock: front room, back room, first hour.
Mock InspectionsThe real inspection, rehearsed before it counts.
Supplier & Vendor AuditsYour name is on their deviation. Audit accordingly.
Post-Market SurveillanceSignals found by you, not filed against you.
M&A Due DiligenceRegulatory and quality diligence before the deal signs.The domains where quality is hardest — sterile, advanced therapies, and the clinic.
Proof
Our quality leaders have run and survived the inspections they now prepare clients for — on the manufacturing floor, in the QMS, and across the supplier base. Readiness isn't a document they hand you; it's a state they leave the organization in.
See the work in selected engagements →
Work With Us
Tell us where your quality system stands and what's coming — an inspection, a partner audit, a remediation, or a build from zero. We'll match you with a senior quality lead, usually within one business day.
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