Delivery Model
Managed Services
Retainer-based compliance programmes delivering continuous audit readiness, vendor monitoring, CAPA oversight and regulatory intelligence — across all five practice areas, on subscription. Compliance that never stops, not just when you remember to check.
Continuous Compliance Assurance
Compliance in regulated industries is not a project that completes — it is a continuous state that must be maintained. Regulatory inspections can occur at any time. Supplier risk profiles change. Regulatory guidance evolves. Quality systems drift from their intended state. Organisations that manage compliance episodically — preparing intensively before inspections and then reverting — consistently underperform against those that maintain continuous oversight.
Managed services bring the same expertise and independence as project-based consulting but deliver it as an ongoing programme rather than a series of discrete engagements. Instead of engaging Sthira Assure reactively, managed services clients benefit from continuous monitoring, structured reporting and proactive identification of emerging compliance risks — before they become findings.
These are not separate services — they are the same audit, assurance, data integrity, quality systems and regulatory intelligence capabilities delivered under a continuous oversight model. Every managed service maps directly to one or more of our five practice areas. The expertise is the same; the delivery model is designed for sustained compliance rather than point-in-time assessment.
Practice Areas Covered
Discuss Managed Services
Speak with our team about a continuous compliance programme for your organisation.
Request a ConsultationService Components
Managed services engagements are built from the following components, scoped and combined based on each organisation's specific compliance requirements.
Continuous Compliance Monitoring
Monthly compliance health scoring against agreed inspection criteria, with issues surfaced before they become findings. Covers quality system performance, deviation and CAPA trends, training compliance and document management status.
Audit Readiness Monitoring
Quarterly readiness reviews keeping your organisation inspection-ready at all times — not only in the weeks before a regulatory authority visit. Structured against the specific inspection criteria of your applicable regulatory authorities.
Vendor Compliance Monitoring
Ongoing qualified vendor status tracking, periodic check-ins and alerts when supplier risk profiles change. Covers approved supplier list currency, quality agreement validity, regulatory status changes and CAPA closure monitoring.
CAPA Oversight
Independent monthly review of open corrective and preventive actions — effectiveness checks, timeline compliance and escalation where closure quality or schedule is at risk. Provides quality leadership with objective CAPA system oversight.
Regulatory Intelligence Subscription
Curated monthly briefings on EMA, FDA, MHRA, CDSCO and international guidance changes — with specific impact assessments for your operations, product portfolio and regulatory markets. Tailored, not generic.
Compliance Analytics & Reporting
Ongoing KPI tracking, trend analysis and board-ready compliance dashboards delivered on a defined cadence. Includes management review input packs aligned to ICH Q10 and applicable regulatory expectations.
Why Continuous Compliance Works
Always Inspection-Ready
Continuous oversight means your organisation is not playing catch-up before an inspection. Readiness is a maintained state, not a reactive sprint.
Independent Assurance
External oversight provides the objectivity that internal quality teams cannot reliably deliver for their own systems. Independent eyes identify what familiarity masks.
Predictable Cost of Compliance
Retainer-based engagements convert variable compliance spend — reactive audits, emergency remediation, for-cause response — into predictable, budgeted programmes.
Regulatory Intelligence Built In
Every managed services engagement includes monitoring of regulatory developments relevant to your operations — ensuring compliance programmes remain current without internal resource overhead.
Frequently Asked Questions
How do managed services differ from project-based consulting?
Project-based consulting addresses specific, defined needs — a GMP audit, an inspection readiness review, a data integrity assessment — and concludes when the engagement objective is met. Managed services are ongoing retainer programmes that provide continuous compliance oversight across one or more practice areas. The same expertise is applied, but the engagement is designed for continuity rather than completion. Managed services are particularly valuable for organisations that need sustained compliance assurance without the overhead of a full in-house team.
Can managed services be customised to our specific compliance needs?
Yes. All managed services engagements are scoped to the specific regulatory environment, product portfolio, operational context and risk profile of the individual organisation. An organisation subject to EU GMP and FDA requirements with a complex supply chain will have a different scope than a single-site manufacturer subject to MHRA requirements alone. Engagement terms, reporting frequency, focus areas and deliverable format are all agreed at the outset.
How quickly can a managed services engagement start?
Managed services engagements typically begin with a baseline assessment to establish the current compliance posture and agree the programme parameters — KPIs, reporting cadence, focus areas, escalation thresholds. This onboarding phase typically takes two to four weeks. Ongoing monitoring and reporting then operates on the agreed schedule. For organisations with urgent compliance requirements, priority onboarding arrangements are available.
What is the minimum engagement term for managed services?
Managed services engagements are typically structured on an annual retainer basis, reflecting the time required to establish monitoring baselines, observe compliance trends and deliver meaningful insights. Shorter-term arrangements are available for specific managed service components. We recommend discussing your requirements with our team to design an engagement that delivers genuine compliance value rather than a fixed-term contract.
Design Your Compliance Programme
Contact our team to discuss your compliance obligations, risk profile and the managed services programme that is right for your organisation.