01 / Detect
Surveillance & intake
- Case receipt & triage
- Scientific literature monitoring
- MedDRA coding
GVP Module VI
All practices
Pharmacovigilance & Drug Safety
A compliant, audit-ready pharmacovigilance system across the EU, UK, and US, from PV system design and QPPV support through individual case and aggregate reporting, signal management, and health-authority inspections.
Governing framework
- In effect
EU GVP
Modules I-XVI · Reg (EC) 726/2004 · Dir 2001/83/EC
- Post-Brexit
UK HMR 2012
Human Medicines Regulations · MHRA guidance
- In effect
21 CFR 314.80
US postmarketing safety · 314.81 · 600.80
- Current
ICH E2B / E2C
E2B(R3) ICSRs · E2C(R2) PSUR / PBRER
Reporting toEMA / PRACEudraVigilanceMHRA GatewayFDA FAERSFDA ESGMedDRA
What we do
Authorisation is the start of a safety obligation, not the end.
Holders of approved products carry a continuing, non-delegable duty to detect, assess, understand, and report the safety profile of their medicines.
That duty runs completely, accurately, and on time in every market where the product is sold. We help biotechnology and pharmaceutical organisations build and run pharmacovigilance systems that meet EU, UK, and US requirements, and that hold up under inspection.
Whether you are launching a first product, expanding into a new region, or strengthening an established safety function, we provide practical, proportionate support across the full PV lifecycle.
The PV lifecycle
One safety system, end to end.
Surveillance, case management, aggregate reporting, risk management, signal detection, and audit readiness, scaled to your stage and resources.
02 / Report
Case & aggregate
- ICSR electronic submission
- PSUR / PBRER / PADER
- Expedited 15-day reports
Modules VI & VII
03 / Assess
Signal management
- Detection & validation
- Prioritisation & assessment
- PRAC interactions
GVP Module IX
04 / Mitigate
Risk management
- Risk Management Plans
- Additional risk minimisation
- Effectiveness review
GVP Module V
05 / Prove
Audit & inspection
- PV system audits & CAPA
- Mock inspections
- PSMF readiness
Modules III & IV
Three regimes, one standard of rigour
EU, UK & US, mapped to the controlling rule.
The obligations diverge across markets. We navigate each on its own terms, and keep your system coherent across all three.
GVP · 726/2004
European Union
Compliance with the EU Good Pharmacovigilance Practices (GVP) and Regulation (EC) No 726/2004 and Directive 2001/83/EC.
PV system & PSMFModule II
Design and maintenance of the pharmacovigilance system and the Pharmacovigilance System Master File.
QPPVEU QPPV
EU Qualified Person Responsible for Pharmacovigilance support, deputies, and back-up arrangements.
ICSR managementModule VI · E2B(R3)
Case intake, assessment, MedDRA coding, and electronic reporting to EudraVigilance.
Aggregate reportingModule VII
Periodic Safety Update Reports (PSURs / PBRERs) and PSUR single assessment (PSUSA).
Signal managementModule IX
Detection, validation, prioritisation, assessment, and EMA / PRAC interactions.
Risk managementModule V
Risk Management Plans (RMPs) and additional risk-minimisation measures.
Literature, audits & CAPAModule IV +
Surveillance of the scientific literature, PV system audits, and corrective and preventive action.
Who we help
From first approval to multi-region scale.
We scale support from interim QPPV cover and a single periodic report through to building a complete, multi-region safety system.
01
Emerging biotech
Preparing for first approval and launch, and standing up a PV function for the first time.
02
Established pharma
Expanding into new regions and extending an existing safety system across borders.
03
Safety functions in transition
Strengthening, remediating, or outsourcing an existing PV function under pressure.
Practical · Proportionate · Inspection-ready
Compliant on paper, and defensible in the room.
We combine hands-on regulatory experience with a compliance-first mindset, so your pharmacovigilance system holds up in front of an EMA, MHRA, or FDA inspector. Every recommendation is mapped to the controlling regulation and sized to your stage and resources.
Mapped
Every recommendation traced to its rule
GVP module, CFR citation, or ICH reference: never advice without a source.
Proportionate
Sized to your stage
Interim cover, a single report, or a full multi-region build, scoped to your resources.
Defensible
Built for the inspection you will face
Mock inspections and 483-response strategy drawing on direct health-authority experience.
Specialists in this area
Bring us your product, your programme, or your next inspection.
Tell us about your product or programme and we will come back to you promptly.