eQMS · RIM · Pharmacovigilance · CAPA · Regulatory Intelligence

Regulatory Services

Regulatory operations, intelligence and technology — including implementation and validation of eQMS, RIM, LMS, DMS platforms, and CAPA / PV programme design.

Quick chat on WhatsAppHuman review at every gatePart 11 readyISO 9001 & 27001 certified

regulatory compliance serviceseQMS implementationRIM implementationLMS implementationDMS implementationpharmacovigilance servicesCAPA servicesregulatory intelligence services

FDAEMAMHRAPMDACDSCOGAMP 5ICH Q921 CFR Part 11

In short

Regulatory services cover regulatory operations, intelligence and the systems that carry them — eQMS, RIM, LMS and DMS implementation and validation, plus CAPA and pharmacovigilance programme design. Most of this work is continuous rather than project-shaped, which is why it tends to be under-resourced relative to the risk it carries.

8 disciplines

Every regulatory discipline we deliver

Each one has its own page with scope, deliverables and timelines.

Regulatory Compliance

Programme design, gap assessment and remediation across regulated processes — from CMC through post-market.

Learn more about Regulatory Compliance Regulatory Intelligence

Automated tracking of FDA, EMA, ICH, MHRA, PMDA and CDSCO publications, tuned to your therapeutic area and product portfolio.

Learn more about Regulatory Intelligence Regulatory Information Management (RIM)

Product registration, submission tracking, correspondence and label management — implemented and validated end-to-end.

Learn more about Regulatory Information Management (RIM)eQMS Implementation & Validation

Document control, training, CAPA, change control, deviations, complaints — implemented and validated as a single quality operating system.

Learn more about eQMS Implementation & Validation Pharmacovigilance

Case intake, MedDRA coding, narrative writing (with TraceDraft), aggregate reporting and signal detection — as a service or as a technology deployment.

Learn more about Pharmacovigilance CAPA Programme Design

Root cause analysis, effectiveness checks, and CAPA closure discipline — supported by dashboards and reviewer routing.

Learn more about CAPA Programme Design LMS Implementation

Learning Management System implementation and validation — role curricula, training records, and Part 11-grade e-signatures on assessments.

Learn more about LMS Implementation DMS Implementation

Document Management System implementation and validation — draft → in-review → approved → effective → superseded / retired, plus periodic review.

Learn more about DMS Implementation

Validated state

Periodic reviewA set cadence confirms the system still does what it was validated to do

Change controlEvery change is assessed for its impact before it is made

Supplier reassessmentVendor releases and evidence are checked when they change

Deviations and incidentsProblems are investigated and fed back into the record

Validation does not end at go-live. Each of these can move a system out of its validated state, and each brings it back with evidence.

Case study · Pharmaceuticals

Regulatory managed services for a global eQMS estate

A pharma operations arm of a leading research institute had a growing quality-event backlog and slipping KPI compliance.

Read the case study

GreenKPI status across 3 sites

2 quartersTo clear the backlog

3eQMS instances managed

FallingRepeat deviations, quarter on quarter

Tell us what you need from regulatory.

A regulatory lead reviews your situation and proposes the smallest scope that does the job properly.

We reply within one business day
We look at your situation before we quote
You get a clear plan and scope

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Regulatory Services

Every regulatory discipline we deliver

Regulatory managed services for a global eQMS estate

Tell us what you need from regulatory.

Talk to a regulatory lead