🛡️ Chemical & Pharma ERP: Regulatory compliance
Track licences and retention fees, product registrations in every market, changes and what each regulator needs to hear about them, self-inspections across FDA's six systems, 483 responses and CAPA. One calendar, with every due date owned.
Every regulated market accepts dossiers in the Common Technical Document format. Pick a module to see what it holds.
Pick a change. Each market lights up with the usual category. Illustrative only: your regulatory team sets the real mapping, and the system applies it every time.
FDA inspects drug plants by system. Here's a demo site's readiness score for each, from its own self-inspections and open items. Pick a system to see what's pulling it down.
What happens after FDA leaves. The 15-business-day response is FDA's recommendation; the other days are an example plan. The system turns each observation into tracked work.
What each one asks for, and where it's handled in the suite.
Nine capabilities, each linked to the related module.
Send us your licence list and markets. We'll show your full compliance calendar and the next 12 months of due dates in a live demo.
Build my compliance calendarSee the Chemical & Pharma ERPSix steps to move licences, markets and QA onto one system.
What changes once compliance runs on one system.
Every due date has an owner and a reminder.
Market impact known before a change is made.
Evidence for each system, one click away.
483 responses built from linked records.
From domestic plants to exporters in regulated markets.
One integrated system.
Industries and services connected to regulatory compliance.
Answers for regulatory affairs, QA heads and plant owners.
It keeps track of every licence, registration and filing, assesses changes for their impact in each market, runs self-inspections and CAPA, and keeps the evidence inspectors ask for linked to the records that produced it.
Since the 2017 amendments to the Drugs and Cosmetics Rules, licences stay valid as long as the retention fee is paid every five years and the licence isn't suspended or cancelled. The system tracks each retention fee date with reminders.
Each change type is mapped to how each market treats it: record and report later, notify, or approval before use. The mapping is set up with your regulatory team and shown before the change is approved.
Yes. Self-inspections are organised around FDA's six systems: quality, production, facilities and equipment, laboratory controls, materials, and packaging and labelling. Open items show where you're exposed.
Each observation is logged, investigated and turned into CAPA with owners and dates. FDA's March 2026 draft guidance recommends responding within 15 business days, and the response pack is built from the linked records.
It keeps the data behind CTD module 3: formulas, specifications, validation and stability. Dossier publishing itself is usually done in a specialist tool, and we can integrate with it.
Yes. Gap assessments, self-inspections, CAPA and the documents Schedule M asks for live in one place and link to batch, QC and equipment records.
Yes. Batches, deviations, OOS results, complaints, changes and stability for each product are rolled up for review.
As an estimate, 6 to 10 weeks, depending on how many licences, markets and products you have and how many QA records need to move across.
Tell us your licences, markets and products. We reply within 4 business hours and can demo with your own compliance calendar.