Thirteen capabilities. One methodology. One page.
Everything ClariSure does, in one place: quality systems, risk, remediation, audits, supplier and manufacturing quality, validation, post-market, pharmaceutical GxP, regulatory support, integration and quality leadership. Every engagement follows the same arc — what changes is the subject matter, not the discipline.
Four ways to engage us.
The capability answers what needs doing. The engagement model answers how — and how much of the work sits with you.
Advisory & Consulting
You have a defined problem. ClariSure scopes it, leads it and delivers it — assessment, strategy, remediation, implementation or transformation.
Interim & Fractional Leadership
A named quality leader in the seat, with defined scope, authority and term — through a transition, a remediation or a growth stage.
SME & Staff Augmentation
Qualified experts deployed by industry, specialty, regulation, product type, location and duration. You direct the work; we supply the expertise.
Managed Quality Services
ClariSure operates a defined quality function under an agreed governance model. See how it works →
Under any engagement model, regulatory responsibility, decision authority and legal accountability remain with the manufacturer, sponsor, specification developer, Marketing Authorization Holder or other legally accountable entity. ClariSure does not assume the regulatory obligations of the regulated entity.
The thirteen capabilities
Quality Systems
Most organizations do not have a quality system problem. They have three quality systems wearing one name, and a procedure set that has grown by accretion for a decade.
ClariSure designs, assesses, remediates and harmonizes quality management systems so that a single governed system satisfies FDA, EU MDR, MDSAP and your own operational needs — rather than three parallel systems that contradict each other in the places nobody has looked yet.
Design Quality & Product Development
Design controls fail in one of two directions: a file assembled retrospectively to satisfy an audit, or a process so heavy that engineering routes around it.
ClariSure builds design control processes that engineering will actually use, and design history files that read as an argument rather than an archive.
Integration & Transformation
Acquisitions create a quality problem with a deadline attached. The diligence identified it; the integration plan under-scoped it; and the first post-close audit is already scheduled.
ClariSure has led quality integration for acquired businesses — harmonizing legacy quality elements, closing inherited remediation commitments, and bringing sites onto a single governed system without stopping production. The discipline is sequencing: what must be common before the next audit, what can stay local, and what should be deliberately left alone.
Interim & Fractional Quality Leadership
Interim leadership is usually sold as anonymous staff augmentation. It should not be. The value is in a specific person with specific authority, held long enough to be accountable for the outcome.
ClariSure provides named interim and fractional quality leadership with defined scope, defined authority and a defined term — backed by the Expert Network when the role needs surge capacity rather than another leader.
Risk Management
Risk management is the most-cited area in FDA’s post-QMSR inspections. It is also the area most often treated as a design-file artifact rather than an operating discipline.
ClariSure builds risk management as a governed system: one structure connecting product risk, process risk, supplier risk and post-market signal, with defined ownership, defined triggers and traceability that holds up when an investigator follows a complaint back to a hazard.
Compliance & Remediation
Remediation fails for predictable reasons: the corrective action addresses the example rather than the cause, effectiveness checks measure activity rather than outcome, and nobody owns the system after the consultant leaves.
ClariSure runs remediation as a program with governance, not as a document exercise. That includes the uncomfortable part — telling you which findings indicate a systemic problem that will recur under a different heading if it is only patched.
Audits & Inspection Readiness
On 2 February 2026 FDA replaced QSIT and the legacy device compliance programs with Compliance Program 7382.850. The four subsystems are gone.
The change with the widest consequence: the former protection over management review records, internal audit reports and supplier audit reports no longer applies. Those records are now inspectable. Most organizations have never written them expecting an outside reader.
Post-Market Quality
Complaint handling is among the most frequently cited areas in device inspections, and the underlying issue is usually connection: complaints are processed correctly and never reach the risk file or the CAPA system.
ClariSure builds post-market quality as a connected system: intake, evaluation, reportability decision, investigation, trending, and defined feedback into risk and CAPA.
Supplier Quality
Purchasing controls are among the most consistently cited areas in device inspections, and the citation is rarely that the supplier was unqualified. It is that the qualification cannot be evidenced.
ClariSure builds supplier quality programs that generate the record as a by-product of doing the work, rather than as a retrospective exercise before an audit.
Manufacturing & Operations Quality
Manufacturing quality is judged by a simple test: can you release product, and can you defend the release. Everything else is upstream of that.
ClariSure works on the operational side of quality — validation strategy, manufacturing controls, deviation handling and the sterility assurance disciplines that govern terminally sterilized and aseptically processed product.
Validation & Digital Quality
FDA finalized its Computer Software Assurance guidance in September 2025. It did not lower the bar. It moved the effort to where the risk is — and raised expectations on suppliers and cloud services.
ClariSure helps organizations apply risk-based assurance to production and quality system software — including, increasingly, the AI-enabled capabilities that arrive inside eQMS and regulatory information platforms already under licence.
Pharmaceutical & GxP Quality
Most consultancies market the full GxP alphabet without distinguishing between capability they hold and capability they can find. We draw that line explicitly, because a knowledgeable buyer will find it on the first call anyway.
Beyond that operational core, pharmaceutical capability is delivered through qualified Subject Matter Experts in the ClariSure Expert Network — who bring the GMP quality systems, investigations, technology transfer and ICH governance depth that a specific engagement requires. ClariSure holds the client relationship, the project governance and the quality expectations.
Regulatory Support
ClariSure is a quality, compliance and risk firm. Regulatory support here means the quality-side work that determines whether a regulatory position is defensible — not submission authorship.
Where an engagement requires regulatory affairs strategy or submission authorship, it is delivered through qualified Subject Matter Experts in the ClariSure Expert Network, under ClariSure project governance and with the delivery team named up front.
One arc, applied to every capability.
Five of the seven steps happen after the assessment is written — because findings are easy, and closing them is the work.
Understand the system as it actually operates, not as it is documented.
Rank findings by patient risk, compliance exposure and business impact.
Address systemic cause, with evidence a regulator will accept.
Put the process, the procedure and the people in place.
Verify it works — and document that verification.
Governance, metrics and management review that keep it working.
Feed post-market and operational data back into risk and design.
Five of seven steps
happen after the
assessment is written
How do we know which capability we need?
Can capabilities be combined in one engagement?
Can ClariSure certify our quality system?
How quickly can an engagement start?
Let’s solve the quality or compliance challenge standing in your way.
Tell us what you are dealing with. We will tell you honestly whether it is something ClariSure should take on, and what the path forward looks like.