An innovative Regulatory Information Management system designed to boost efficiency and team collaboration. Developed in Algeria by an experienced pharmacist and a team of skilled developers and designers — affordable, accessible, and tailored to the unique needs of the region.
Seven kinds of chaos every RA team knows — and the RAPSKEY clarity that eliminates them.
“Before the hour, it's not the hour; after the hour, it's no longer the hour.” — Jules Jouy
The chaos
The date on the registration decision was yesterday. You forgot to submit the renewal file six months ago. Your product now falls under the Sunset Clause: it is technically illegal. A missed renewal isn't a mistake — it's a burial.
The RAPSKEY clarity
You don't "remember" a renewal. You simply get notified when it's time to act.
The solution
Automated Lifecycle Alerts: the system captures renewal data and triggers immutable alerts at D-365, D-180 and D-90 to launch the project. Tasks are generated automatically according to local regulatory requirements.
“One single being is missing, and the whole world feels empty.” — Alphonse de Lamartine
The chaos
Your Regulatory Manager just resigned. You're not sad — you're terrified. Why? Because the history, the passwords and the logic of your dossiers live in their head.
The RAPSKEY clarity
Disconnect knowledge from the individual. Company memory lives in the system, not in the person.
The solution
Handover & Centralized Memory: all work, decisions and documents are captured in a structured environment. When someone leaves, a built-in Handover Template with defined tasks preserves knowledge and keeps the business running.
“Everything fears time... except the Pyramids.” — Arab proverb
The chaos
Your team builds the CTD dossier the way one builds a tomb: dragging heavy PDFs across the digital desert, stone by stone. Majestic — but it takes an eternity. You're launching a generic drug, not a historical monument.
The RAPSKEY clarity
Stop the forced labor. Don't build the dossier — generate it in one click.
The solution
Automated eCTD Compiler: in the product's document center, the system automatically builds the CTD skeleton according to ICH and ANPP guidelines. PDFs load into each section, and a final ZIP is generated instantly for every submission sequence.
“Whatever you do, don't sleep.” — A Nightmare on Elm Street
The chaos
It's 11:58 pm. You're drifting off to sleep when suddenly... the flash. "Did I send the commitment letter on time?" The deadline you forgot just sank its fangs into your neck.
The RAPSKEY clarity
Sleep soundly. The system keeps watch for you.
The solution
Real-Time Notification Center: a centralized dashboard that automatically pushes deadline alerts (in-app & email) for every commitment. No deadline ever depends on your memory alone again.
“المندبة كبيرة والميت فار” — Algerian saying
The chaos
It all starts with a simple question from the CEO: "What's the submission date?" The answer isn't visible, so the email gets forwarded. Then escalated. Then the VP is cc'd. By 2 pm the subject line says "URGENT" and it's general panic. A simple check has mutated into a regulatory tragedy.
The RAPSKEY clarity
Don't answer the question. Eliminate the need to ask it.
The solution
Democratized Access: key data (dates, statuses, prices) is visible and accessible to Management, Marketing and Supply Chain. The CEO no longer emails — they simply look.
“Once bitten, twice shy.” — French proverb
The chaos
You arrive at the submission desk with trembling hands, reliving the flash of the last refusal: the sound of the "INADMISSIBLE" stamp over one missing signature. It wasn't just an administrative rejection — it was real trauma.
The RAPSKEY clarity
First Time Right. No rework. No flashbacks.
The solution
Quality Control (QC) Checklists: the system generates detailed, step-by-step control tasks that users keep updated to the latest regulatory requirements.
“The microbe is nothing. The terrain is everything.” — Louis Pasteur
The chaos
Regulatory Affairs isn't just another department — it's the heart of your company. When Regulatory falters, it's not a local problem. It's full-body sepsis.
The RAPSKEY clarity
RAPSKEY integrates the entire regulatory anatomy into one living ecosystem, connecting the six vital signs of your business:
The solution
1. Products (the Data Heart) · 2. Documents (the Memory) · 3. Projects (the Nervous System) · 4. Analytics (the Pulse) · 5. Insights (the Brain) · 6. Team Performance (the Muscle). The result? A healthy, thriving organism.
Click a card to flip it.
Digitally centralize all product details for easy access and streamlined compliance — medicines and medical devices, across the full lifecycle.
Streamline submissions, renewals and variations with built-in templates — 7 project categories with pre-loaded ANPP templates.
Manage eCTD submissions and adapt seamlessly to evolving e-submission requirements from the Health Authorities.
Stay updated with the latest guidelines and requirements from Health Authorities.
Generate advanced reports and queries to track performance, compliance and deadlines.
Foster collaboration with innovative gamification features that motivate your team to hit regulatory milestones.
Tailored to local regulatory requirements, with ANPP templates included and kept up to date.
Easy to learn and navigate with minimal training.
Competitive pricing and dedicated local support.
SaaS cloud or on-premise, with secure local hosting and a modular full-stack web architecture.
Tell us about your portfolio and your team — we'll show you exactly how RAPSKEY fits your regulatory operations.
Request a demo