GxP audit and quality assurance services
Independent site, vendor, process and TMF audits, and mock inspections before the real one.
The problem we solve
The audit you commission finds less than the inspection you did not plan for.
Quality systems are threatened by drift: a vendor that changed its process, a site that stopped filing source notes, a TMF that is complete on paper and incomplete in the system. Internal teams are too close to see it, or too busy.
Vakula auditors are experienced, independent and specific. Reports name the gap, the evidence and the fix, and we can stay to help close the CAPA.
Tell us what you need
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What we do
GxP Audit & Quality capabilities
Investigator site audits
GCP compliance, source data, consent and investigator oversight; inspection preparation and mock inspections.
Vendor and supplier audits
CROs, central labs, IRT, software providers and other service providers against your requirements.
Trial master file audits
Completeness, contemporaneousness and quality of the TMF, with remediation support.
Clinical data and CSR audits
Database, listings and clinical study report audits before submission.
Process audits
Internal and external procedures reviewed for gaps and risks, with improvement recommendations.
Regulatory audit support
GCP/GLP/GMP training, submission document audits and follow-up after regulatory inspection findings.
How an engagement runs
What happens after you contact us
Intake call
A consultant who works in this function takes the brief: scope, systems, regulatory context, timeline and budget band. Same day where possible.
Proposal and people
Within a few business days you get a written scope or a shortlist of named consultants with availability and rates. No generic CVs.
Kick-off under a clear SOW
Deliverables, acceptance criteria, reporting cadence and escalation path are agreed in writing before work starts.
Delivery with oversight
A Vakula engagement lead stays accountable for quality and continuity, including cover if a consultant rolls off.
Questions
Before the first call
Are your auditors independent of your staffing business?
Yes. Audit engagements are scoped and delivered separately, and we do not audit work performed by our own consultants.
Do you offer mock FDA inspections?
Yes, for sites and sponsors, including interview coaching and document readiness reviews.
How fast can an audit be scheduled?
Typically within two to four weeks, depending on site availability and travel.
What does the report contain?
Findings graded by criticality, evidence, reference to the regulation or SOP, and recommended corrective actions.
Related
Adjacent services
Start with one requirement.
Send us a role, a scope or a problem. We come back with a plan and a named consultant, not a sales deck.