Regulatory affairs

eRA

Regulatory Affairs Management Platform

Manage registrations, submissions, variations, renewals and health authority interactions in one controlled regulatory platform.

eRA connects product and country strategy with registration planning, procedure execution, authority interactions, controlled documents, Marketing Authorisations and post-approval lifecycle management. Teams work from one traceable data model instead of rebuilding regulatory context across spreadsheets, email and shared folders.

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Part of the e-line product family

At a glance

eRA quick overview

Best for: Regulatory affairs, local affiliates and global submission teams
Replaces: Spreadsheets, shared folders, emails and local regulatory trackers
Core outcome: Controlled regulatory lifecycle visibility across products, markets and commitments
Deployment: Customer infrastructure or managed environment; integrates with documents, portfolio and launch systems
Compliance: GxP-ready workflows, permissions, traceability and audit trail; validation support available
Licensing: Flexible licensing not tied to the number of users
Key capabilities: Registration and submission planning
Authority communication
Variations and renewals
Commitments and readiness tracking

The regulatory gap

Regulatory operations are too critical to be managed in disconnected trackers

Regulatory Affairs teams manage complex product portfolios, country-specific requirements, procedures, authority questions, document dependencies, renewals and post-approval changes. Information is often spread across spreadsheets, emails, shared folders and local trackers, making it difficult to understand what is due, what is delayed, what requires action and where regulatory risk is increasing.

eRA turns that fragmented agenda into a connected process: every planned market action can be followed through its procedure, events, documents and decisions to the resulting authorisation, renewal, variation and downstream packaging impact.

Disconnected regulatory sources consolidated into eRA Regulatory Cockpit

eRA in motion

See how regulatory work comes together in one controlled workspace

A short product walkthrough showing how eRA supports regulatory portfolio visibility, submissions, lifecycle activities and authority interactions.

What eRA helps you manage

eRA gives Regulatory Affairs teams one structured place to manage lifecycle status, submissions, deadlines, authority communication and traceable decisions.

Projects & Product Portfolio

Structure projects, countries, reference products, core products, registered products, packagings and partners as one connected regulatory portfolio.

Registration Planning

Plan new registrations, variations, renewals, transfers and line extensions by product, market, route, packaging, owner, partner and target date.

Procedures & Submissions

Run National, MRP, DCP, Centralised and other procedures with countries, roles, activities, milestones, events and controlled status transitions.

Authority Questions & Regulatory Clock

Capture submissions, validation, questions, responses, clock stops, opinions and decisions in a country-aware regulatory timeline.

Marketing Authorisations

Manage MA numbers, holders and partners, approval and expiry dates, lifecycle status, packaging coverage and links to originating procedures.

Variations & Product Information

Record variation classification, affected MAs, field-level changes and product-information changes with document, country, packaging and artwork impact.

Renewals, Expiry & Sunset Risk

Monitor renewal history, upcoming expiry, overdue authorisations, sunset deadlines, withdrawals and packaging launch status across the MA portfolio.

RA Tasks, My Work & Notifications

Turn portfolio gaps into RA tasks and give each user a focused queue of owned procedures, activities, open questions, deadlines and notifications.

Controlled Regulatory Documents

Link documents to regulatory entities, manage versioned files and approval states, preview content and search across extracted text and metadata.

Workflow, Rights & Audit Trail

Enforce role-based transitions and process preconditions, capture reasons and comments and retain old/new values in a traceable audit history.

Reports & Connected Data

Explore pipeline, workload, procedures, documents and trends through management reports, saved views, global search and a visual entity browser.

SKU & Downstream Integration

Connect product-country-packaging matrix entries with SKUs and expose controlled regulatory and PI-change data to downstream artwork processes.

Contextual AI Smart Actions

Run on-demand risk, readiness, lifecycle, document and authority-question analyses against the context of the selected regulatory record.

Connected regulatory lifecycle

Follow the complete path from portfolio strategy to post-approval maintenance

eRA preserves the relationships between a project, its scientific product definition, registered variants, country and packaging scope, planned regulatory actions, executed procedures and resulting Marketing Authorisations. The same context then supports renewals, variations, product-information changes, reporting and integrations.

PortfolioProduct & MarketsRegistration ItemProcedureEvents & DocumentsDecisionMarketing AuthorisationRenewal / Variation

One platform for regulatory control and lifecycle visibility

From registration portfolio to procedure execution, eRA connects regulatory work with ownership, deadlines, evidence and management visibility.

Start with a live management view of the RA portfolio

The reporting workspace combines portfolio totals, registration and procedure funnels, active MAs, items requiring attention, owner workload, documentation status and trends. RA leads can move from an executive snapshot into the records behind each number without rebuilding reports in spreadsheets.

eRA Reports overview with regulatory portfolio KPIs and pipeline charts

Turn regulatory strategy into a structured registration plan

Registration Items define what the organization intends to register or change, for which product and countries, through which route and by when. Owners, partners, priority, target submission, approval and launch dates, packaging selection and generic-product data remain together as the plan moves toward execution.

eRA Registration Plan with planned regulatory actions, routes, owners and target dates

Run every procedure with its countries, events and responsibilities

A procedure connects its regulatory scope and workflow state with participating countries and roles, country cases, activities, milestones, submissions, authority questions, product-information changes, variations, affected MAs, documents and audit history. Templates can create repeatable event and activity structures for the whole procedure or individual countries.

eRA Procedure Detail with workflow status, regulatory milestones and event timeline

Make authority interactions and regulatory time visible

Record submission, validation, authority question, deficiency letter, response, clock stop and restart, opinion, decision, approval or rejection as structured events. Questions carry response deadlines and status, while the timeline separates procedure-wide and country-specific events so teams can see where time was spent and what must happen next.

eRA procedure event entry with submission, authority-question, response and clock event types

Keep approved products under active lifecycle control

The MA workspace brings together authorisation identifiers, product, country, owner, MAH and local partner, dates, packagings, renewals, variations, related procedures, documents and audit history. The portfolio highlights renewals due, expiry and overdue records, sunset-clause exposure and withdrawals before they become last-minute issues.

eRA MA Portfolio with renewals due and sunset risk

Give every specialist a clear, personal work queue

My Work collects the user’s active procedures, assigned activities, open authority questions, approaching deadlines and notifications. RA Tasks also expose gaps between product-country planning and existing Registration Items, allowing teams to turn missing coverage directly into a planned regulatory action.

eRA My Work with owned procedures, assigned activities and open authority questions

Keep documents in regulatory context and under control

Documents can be linked to projects, products, Registration Items, procedures, MAs and reference products. Each logical document retains versioned files, approval or rejection status, preview, metadata, checksum, linked entities and history; full-text search covers both metadata and extracted file content.

eRA Document Detail with approval workflow, metadata, linked entities and version history

Explore the relationships behind every regulatory record

The visual Data Browser follows the chain from project and product through Registration Item and procedure to country, packaging and MA. Search, configurable depth and relationship filters help users understand context that would otherwise be scattered across separate lists and trackers.

eRA Data Browser showing connected regulatory entities

Connect regulatory scope with packaging, SKU and launch execution

The Project Matrix maps products and packagings across countries and turns registration or launch intent into traceable coverage. Matrix entries synchronize SKUs, while integration endpoints make controlled product, packaging, country, MA and PI-change data available to downstream artwork workflows.

eRA Project Matrix mapping registered products and packagings across countries

Built for the e-line ecosystem

eRA is designed to work as the Regulatory Affairs platform within the e-line ecosystem. It owns regulatory lifecycle data and workflows, while connecting with surrounding systems for documents, portfolio management, launch readiness, quality, laboratory data and other domain-specific information.

eRA does not duplicate surrounding systems. It connects regulatory work with the wider pharmaceutical lifecycle.

ePM

eRA

eGO

eTRANSFER

eAW

Artwork execution follows regulatory and launch change context.

Supporting systems across the lifecycle

eDOCSeQCPeLABeTMF

Typical use cases

eRA supports operational questions that regulatory teams need to answer across products, markets and lifecycle activities.

Regulatory portfolio oversight

Which products and markets require regulatory attention?
Which registrations are delayed or at risk?
Which procedures are active this month?
Which renewals, expiries or sunset risks need management attention?

Submission and procedure execution

What needs to be submitted and when?
Which event, document or workflow precondition is still missing?
Who owns the next action?
What changed since the last regulatory meeting?

Variations, renewals and lifecycle management

Which renewals are approaching?
Which markets are affected by a product change?
Which MAs and packagings are affected by a variation?
What is the regulatory impact of a planned launch or change?

Regulatory readiness and compliance control

Is the registration record complete?
Are all decisions and approvals traceable?
Which activities are overdue?
What should be reviewed before an audit, inspection or management meeting?

AI Smart Actions

AI-assisted Regulatory Affairs management

Smart Actions run on demand from the record a user is reviewing. eRA assembles its structured context and can assess portfolio health, country coverage, Registration Item risk, procedure readiness and timelines, variation impact, MA renewal or sunset risk, document completeness and authority-question classification or response drafting. Results are stored with provider, model, score, verdict, summary and structured findings for human review.

ProjectProductRegistration ItemProcedureMAQuestionDocument

Example eRA actions

More contextual actions across registrations, submissions, commitments and authority interactions.

RegistrationMarketsDossierCommitmentsDeadlinesAuthority history

Scoped regulatory outputs

Each action runs from the selected regulatory record and produces a focused summary, readiness check, risk note or response draft for review.

eRA Activity Generator Smart Action result with prioritized regulatory activities and structured findings — **Activity Generator result**Example output generated for a specific eRA procedure.

Contextual AI Smart Actions

Regulatory Affairs fit

Designed around pharmaceutical Regulatory Affairs reality

eRA supports long product lifecycles, multi-country registration management, submission planning, authority communication, variations, renewals, commitments, controlled workflows, audit trail and regulatory readiness. It is built for organizations that need more than generic task tracking, but do not want regulatory operations to remain hidden in spreadsheets and shared folders.

Regulatory StrategyRegistration PlanningSubmissionProcedure TrackingApprovalVariationsRenewalsLifecycle Maintenance

Benefits

What eRA helps you achieve

Better visibility across products, markets and regulatory lifecycle activities

Clearer control of submissions, procedures, authority questions and regulatory timelines

Earlier identification of missing inputs, overdue actions and deadline risks

Stronger traceability of regulatory decisions, approvals and evidence

More efficient preparation for regulatory meetings, audits and inspections

Better connection between regulatory execution, packaging, SKU, artwork and launch decisions

Less manual reporting and fewer disconnected regulatory trackers

Request a demo

Bring structure, control and visibility to Regulatory Affairs

See how eRA can help your teams manage registrations, submissions, variations, renewals, authority interactions and regulatory commitments in one connected platform.

Request a Demo