We help Marketing Authorisation Holders meet their pharmacovigilance obligations under EU Regulation 2019/6, so they can focus on their products.
From individual case processing to the annual benefit-risk review. We cover the full scope.
Named or deputy Qualified Person Responsible for Pharmacovigilance for your EU veterinary marketing authorisations. Resident in the EU, available to competent authorities.
We handle intake, validation, VeDDRA coding, ABON causality assessment, follow-up, and EVVet submission within the 30-day regulatory timeline.
Continuous monitoring of your pharmacovigilance data, signal detection and evaluation, and preparation of the annual benefit-risk review report for IRIS submission.
We screen PubMed, CAB Abstracts, and key veterinary journals by active substance and target species. Biweekly or monthly, with full documentation.
Real examples of how we handle pharmacovigilance obligations on behalf of our clients.
A veterinarian in the Netherlands reports unexpected sedation lasting 18 hours in two dogs following administration of a licensed anti-parasitic product. One animal required veterinary observation overnight. No fatalities.
Report arrives via email from the reporting veterinarian. We assess seriousness criteria under Reg. 2019/6 Art. 76: the extended sedation in two animals qualifies as a serious adverse event. Case is entered into the PV database and a unique case ID is assigned.
Clinical signs are coded using VeDDRA terminology. ABON causality assessment is performed: the temporal relationship between administration and onset, the absence of alternative explanations, and the known pharmacological profile of the active substance are evaluated. Causality: Possible.
Additional information requested: concomitant medications, breed and body weight of both animals, outcome at 48 h. Follow-up received on Day 8. Both animals recovered fully. Case updated in the database.
Final case narrative compiled, quality-reviewed, and submitted electronically via EVVet to the European Medicines Agency. Submission receipt archived. Client notified with case summary. Regulatory deadline: 30 days for serious cases.
Because the event was unexpected, the case is tagged in our signal management system. At the next quarterly signal review, we will assess whether a pattern is emerging across the product's full adverse event history and whether SPC update or IRIS notification is warranted.
All individual case safety reports (ICSRs) received in the period are retrieved from the PV database and stratified by active substance, target species, and event term.
We apply proportional analysis and clinical review to identify disproportionate reporting of specific VeDDRA terms. Literature hits from the monitoring period are cross-referenced.
The potential vomiting signal is evaluated against cumulative case data, the product's approved SPC, and published pharmacokinetic data. A causality assessment is applied at the aggregate level.
Findings are consolidated into the annual benefit-risk review report, covering all products in the portfolio. The report is submitted to the competent authority via IRIS by the regulatory deadline.
Every engagement with DGF produces documented, audit-ready outputs. Here is what a client with a full PV support retainer receives:
Fully coded, causality-assessed, and EVVet-submitted reports for every adverse event received. Each case archived with full audit trail and submission receipt.
Summary of all ICSRs received in the period, signal detection findings, and recommended actions. Written in plain language for non-PV management teams.
Biweekly or monthly screening results from PubMed, CAB Abstracts, and target journals. Relevant publications flagged, assessed for reportability, and archived.
Full narrative report covering the product's benefit-risk balance for the reference period, submitted to the competent authority via IRIS by the regulatory deadline.
Pharmacovigilance System Master File kept current: annex updates, deviation log, QPPV contact list, and system description. Ready for inspection at any time.
An EU-resident, competent-authority-accessible Qualified Person Responsible for Pharmacovigilance listed on your product authorisations throughout the engagement.
Four things that actually matter when you are choosing a PV partner.
We only work in veterinary pharmacovigilance. Our SOPs, templates, and expertise are built around Regulation (EU) 2019/6 and what it actually requires of veterinary MAHs. No human pharma crossover.
We work in English, Spanish, and German. If you are dealing with EMA, BVL, or AEMPS, you do not need a translator in the room.
I trained as a veterinarian, then moved into regulatory affairs at a national competent authority, then into industry. I know how both sides read a dossier, and I know what inspectors look for.
Retainer, per case, or project based. One product or twenty. We work with whatever your situation actually is, not a fixed package.
Practical notes on veterinary pharmacovigilance, EU regulation, and animal health compliance.
Most small MAHs think pharmacovigilance starts and ends with adverse event reporting. Under EU Regulation 2019/6, it covers five distinct obligations, each with its own deadlines.
Safety monitoring of a veterinary medicine is a chain of linked steps: detect, report, assess, submit, act. Miss one link and the whole chain breaks.
Three reporting errors that turn a routine case into a regulatory finding: late initial reports, missing causality assessments, and inconsistent case narratives.
I trained as a veterinarian and moved into regulatory affairs. I have worked on the evaluation side at a national competent authority and on the industry side for animal health and crop protection products. I know how the EU market access process works from both ends.
I set up DGF because there is a real gap in the EU veterinary market. Most MAHs need solid pharmacovigilance but do not have the volume or the budget for a large CRO. That is the space we work in.
Based in Hamburg, Germany.
Tell us about your situation and we will respond within one business day. No obligation, no sales pitch.