Services
A CRO with a platform: we take regulated work off your desk. AllesEra does not e-sign and does not submit to EDA.
Named QPPV retainers, case and signal clocks, and system packs attested before filing.
QPPV Agent is an AllesEra platform — one screen for what is due, overdue, and already evidenced. Your named QPPV attests; the platform does not e-sign or submit to EDA.
Receive, assess, and manage adverse event reports. Expedited serious-case handling and follow-up coordination with a submission-ready trail.
Local detection, health-authority alerts, and emerging safety issues on the five-working-day Egyptian business calendar.
PSUR / PBRER packs and other periodic safety reports with an audit trail your QPPV can defend.
Product-level RMP and aRMM drafts, held apart from PSMF and PSSF, attested before filing.
PSMF, Summary of PSMF, and national PSSF as versioned packs — never e-signed or submitted by the platform.
Registration and lifecycle work for Egyptian MAHs: dossiers, variations, renewals, and labeling that stays aligned with the approved dossier.
Variations, renewals, and holder risk handled by the same house that holds your safety work.
Drafting and updating Patient Information Leaflets and Summaries of Product Characteristics against the approved regulatory dossier.
Translating approved text into finished packaging and leaflet artwork that meets health-authority formatting rules.
Line-by-line verification against the last approved reference before submission or print.
EDA track-and-trace and GS1-compliant identifiers. We map requirements, scope providers, and oversee implementation against your lines and volumes.
EDA and MENA track-and-trace obligations mapped to your packaging sites and SKUs.
Standard setup, service-provider vetting, competitive quotation, and implementation oversight.
Data reporting, system integration, and ongoing support once lines are live.
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.
The named seat: clocks, evidence, and what inspectors ask for.
Dossier and lifecycle basics without hiring for every gap.
How PV and RA buying works in Egypt — portfolio risk and advisory pathways.
Quality, regulatory intelligence, and business-development advisory — available under Company when your portfolio needs them.
PV QMS, SOPs, inspection readiness, and CAPA trails on retainer.
Regulatory systems and QMS
Pharmacovigilance system design and QMS frameworks aligned to the authorities that govern your Egypt operations.
Audits and inspection readiness
Gap assessment, mock audits, and remediation planning before the inspector arrives.
SOPs and records
Write and maintain SOPs with a document trail you can show in an inspection.
EDA circulars, label and safety actions, and competitor regulatory activity tracked for Egyptian MAHs.
Market monitoring
Tracking of regulatory decisions, approvals, label changes, and safety actions that affect your portfolio.
Competitive and trend reports
Competitor submissions and approvals, plus tailored reports on markets you care about.
Feasibility, portfolio selection, and market-entry structure for Egypt — scoped advisory before you commit to a retainer.
Feasibility and planning
Market sizing, regulatory and commercial feasibility, risk identification, and go/no-go recommendation.
Portfolio selection
Therapeutic gap analysis, competitive benchmarking, and sequencing against lifecycle plans.
Market entry and distribution
Entry mode, partner identification, and local representation requirements for Egypt.
Mix platform seats, named retainers, and advisory against portfolio size and inspection pressure. The catalogue and rates below show what sits in each offer.
The pharmacovigilance and registration work your team already has to own, delivered as software, as named people on a retainer, as advisory, or as a mix. Take the whole column or the two rows that hurt.
PlatformPV / QPPV retainerAdvisory + academy
| Work you need done | Pillar | How we deliver | What that looks like |
|---|---|---|---|
| ICSRs — assess, validate, submit, follow-up | Case & deadline | Platform | Case & deadline cockpit + optional PV retainer for named ownership. |
| PSUR / PBRER — prepare, submit, follow-up | Periodic reporting | Platform | Periodic reporting calendar and pack reuse on the platform. |
| RMP / aRMM — revise, submit, HA follow-up | Accountability & evidence | PV / QPPV retainer | Product-level RMP and aRMM drafts with revise-to-authority packs, held apart from your PSMF and PSSF. Your named QPPV attests before filing. |
| PSMF + Summary of PSMF | Accountability & evidence | Platform | Versioned PSMF and a linked Summary of PSMF (GVP Ch.2) with filing packs, attested by your QPPV before anything leaves the platform. |
| National PSSF (+ summary) | Accountability & evidence | Platform | The Egypt national PV sub-system file for multinational MAHs, in its own module with its own summary pathway. |
| Signal management — health-authority alerts + local detection | Signal & ESI | Platform | A signal and ESI evidence file you can escalate from and defend in an inspection, not just a detection log. |
| Authorized QPPV | Accountability & evidence | PV / QPPV retainer | Named QPPV / LSR retainer on software that makes accountability defensible. |
| Safety reporting to HAs and other parties | Case & deadline | PV / QPPV retainer | Submission trail in-platform; retainer covers HA / partner reporting load. |
| Local literature review | Signal & ESI | Advisory + academy | Advisory / academy pathway — local journal watch as a service line. |
| AllesEra Academy — QPPV, RA/eCTD, how this market buys | Cross-cutting | Advisory + academy | A free written syllabus at /site/academy your team can work through at their own pace. |
| PV QMS — SOPs, audits, inspections, CAPA | Accountability & evidence | PV / QPPV retainer | An inspection evidence pack and CAPA trail, with the SOP set written and maintained on retainer. |
| Registration & lifecycle | Registration & lifecycle | Platform | Variations, renewals, and label alignment handled by the same house that holds your safety work. |
| SmPC / PIL content, artwork layout, regulatory QC | Registration & lifecycle | PV / QPPV retainer | Labeling and packaging text kept aligned to the approved dossier before print or submission. |
| Serialization / GS1 track-and-trace (EDA) | Cross-cutting | Advisory + academy | Requirement mapping, provider oversight, and implementation scoped to your lines — Serialization Hub when you are ready. |
| Business development — feasibility, portfolio, market entry | Cross-cutting | Advisory + academy | Feasibility, portfolio selection, and market-entry advisory under Company and Academy pathways. |
| Regulatory intelligence — EDA and market monitoring | Cross-cutting | Advisory + academy | Circulars, label and safety actions, and competitor regulatory activity tracked for Egyptian MAHs. |
Platform seats, named PV retainers, and advisory are scoped against your portfolio in writing. Rates are not published on this page.
Five-pillar gap assessment in about five minutes.
Shape of export and inspection artefacts — fictional fixtures, not a live MAH case.
We reply with scope against your products and inspection pressure — with numbers in writing.
Paying MAHs receive a new Organisation workspace. The public open demo is not a live MAH case.
Start with a free Health Check, open the illustrative sample pack, or send a written RFP against your portfolio.
