eQMS, RIM, PV, CAPA — kept healthy, kept audit-ready.
Ongoing management of regulatory systems and processes, with dashboards, incident response and continuous compliance.
Regulatory managed services run the recurring regulatory workload — submissions and lifecycle maintenance, registration upkeep, intelligence monitoring, CAPA and pharmacovigilance operations — under service levels. The value is continuity: these obligations are continuous, while internal capacity moves with hiring, attrition and whatever project is urgent this quarter.
Outcomes you can expect
- System health SLA
- Compliance KPI
- Incident response
Regulatory Managed Services is delivered by our managed services practice. Where it saves time, the team uses our products: GxP Copilot for validation lifecycle work and TraceDraft for clinical documentation.
Explore related capabilities: Validation Managed Services, Clinical Managed Services, AI Managed Services,
Regulatory Managed Services: Sustained Compliance Operations
Regulatory operations in a product portfolio generate continuous workload that does not align neatly with project timelines: eQMS documents require periodic review, RIM registration records require maintenance as approvals are renewed and variations are filed, pharmacovigilance cases require processing and PSUR authoring, and CAPA records require closure discipline regardless of development milestones. Managing this continuous workload through project-based engagements creates gaps between projects where compliance obligations accumulate.
Cybroscape's Regulatory Managed Services programme provides defined capacity and SLAs for continuous regulatory operations: eQMS health (≥98% of due reviews completed on time; ≥90% of CAPAs closed within target date); RIM update cadence (registration status updates within five business days of approval notification); PV case throughput (≥99% on-time submission rate for expedited ICSRs); CAPA closure discipline with defined escalation at seven days before due date. Monthly eQMS health dashboards give quality leadership real-time visibility without requiring them to manage the underlying activities.
Regulatory Intelligence Under Managed Services
Regulatory intelligence monitoring under managed services provides a monthly regulatory intelligence digest calibrated to the client's product portfolio and geographic markets, covering FDA guidance publications, EMA committee opinions, ICH guideline updates, and MHRA regulatory developments that affect the client's products or operations. High-urgency items — a new FDA guidance affecting a pending submission, a PRAC signal evaluation for a related compound class — are issued as priority alerts within 48 hours of publication with impact assessment and recommended response action.
Managed services are governed through a quarterly business review between the Cybroscape service delivery lead and the client's head of regulatory affairs or quality, covering SLA performance against all defined metrics, significant regulatory events and how they were handled, upcoming regulatory deadlines and preparation status, and any service improvement initiatives from the prior quarter.
See it on your own system.
Bring a URS or a system. We show you the validation package it produces.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan and scope