Regulated work, on the record.
A CRO with a platform for Egyptian marketing authorisation holders. QPPV Agent keeps due, overdue, and evidenced work on Egyptian clocks — named people when you need them.
Walkthrough — scoped reply from someone who does this work. Health Check — self-serve gap check in the practice nav.
an AllesEra platform
QPPV Agent
The accountability cockpit for Egyptian QPPVs and LSRs. One screen for what is due, what is overdue, and what is already evidenced — ICSR and signal clocks on the Egyptian business calendar, pack drafts ready for attestation. Case systems hold the cases. This holds the QPPV seat.
People-only CROs do not ship this cockpit. Safety databases do not own named attestation. AllesEra does not e-sign and does not submit to EDA.
Deadline queue
Egyptian business calendar · EET
| Type | Obligation | Clock |
|---|---|---|
| ESI | Notify EDA | 5 working days |
| ICSR | Serious | 11 calendar days |
| ICSR | Submitted | 14:22 EET |
Illustrative UI — not live tenant data.
What we take off your desk.
One accountable house for Egyptian marketing authorisation holders — pharmacovigilance first, with registration, serialization, and Academy alongside it. Quality, intelligence, and BD advisory sit under Company when you need them.
Pharmacovigilance
Named QPPV retainers, case and signal clocks, and system packs attested before filing.
Regulatory Affairs
Registration and lifecycle work for Egyptian MAHs: dossiers, variations, renewals, and labeling that stays aligned with the approved dossier.
Serialization
EDA track-and-trace and GS1-compliant identifiers. We map requirements, scope providers, and oversee implementation against your lines and volumes.
Academy
Bring your own people up. Free written tracks for the QPPV seat, dossier literacy, and how PV and RA buying works in Egypt — including commercial and BD literacy.
Named people, or advisory.
QPPV Agent is the platform. Add named retainers or advisory against portfolio size and inspection pressure.
- Named retainers
- People who own the PV and QPPV seat against your portfolio size, on the same record the platform keeps.
- Advisory
- Academy tracks, literature watch, BD feasibility, and intelligence when you need judgment without a full retainer.
The boundary
The platform drafts and tracks. A named QPPV signs.
Software can prepare ICSRs, deadlines, and system documents. Liability for what is submitted to the authority stays with the Qualified Person for Pharmacovigilance appointed by the MAH — not with the tool. AllesEra does not e-sign and does not submit on the client's behalf.
Built in Egypt, for Egyptian MAHs.
You get EDA calendars rather than a generic global stack, a team that has sat through the inspector conversation, and a QPPV who can stand in front of an authority walkthrough in Cairo. Being here is the advantage, not a localisation checkbox.
- EDA calendars
- ESI notification on the five-working-day Egyptian business calendar — not a generic Monday–Friday default.
- ICSR clocks
- 15-day serious and 90-day non-serious deadlines tracked from awareness, on the record your QPPV can defend.
- GVP grounding
- Egyptian GVP 2023 and PVGA reception checklists — the documents an inspector expects to see cited.
Talk to us.
Tell us how many products you market in Egypt and when your next inspection or audit lands. You get a scoped reply against your portfolio, priced against your portfolio.
A person who does this work replies, usually within one business day.