Govern Regulatory Submissions

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Governed submission phases — from planning to post-approval knowledge retention

21 CFR

Built to 21 CFR Part 11 standard, e-signatures and audit trail on every dossier action

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Platform replacing Excel, email, and shared drives across your submission team

THE CHALLENGE

Small and mid-size regulatory teams are managing high-stakes submissions with tools built for none of this

An NDA or MAA involves hundreds of documents, multiple authors, review chains across functions, and agency queries on tight deadlines. Most small and mid-size regulatory teams manage this with Excel trackers, email chains, and shared drives — tools with no governed workflow, no real-time document status, and no compliant audit trail.

The result: no one knows the real dossier gap until a deadline is days away, agency queries are managed in email with no searchable response history, and every future submission team starts from scratch because the submission knowledge was never governed in one place.

No Single Source of Truth

Submission documents, milestones, approvals, and agency responses are often spread across Excel trackers, emails, and shared drives.

Without a centralised platform, teams struggle to manage accurate, real-time submission data across multiple functions and workstreams.

Limited Cross-Functional Collaboration

Regulatory, quality, clinical, CMC, and external partners frequently operate in separate systems with limited coordination and visibility.

This creates communication gaps, duplicate work, delayed reviews, and inconsistent execution across the submission lifecycle.

Poor Visibility & Readiness Tracking

Most submission teams lack real-time visibility into dossier readiness, outstanding actions, approval status, and unresolved agency queries.

As submission deadlines approach, teams rely on manual updates and disconnected reports instead of live operational dashboards.

Knowledge & Compliance Risks

Critical submission decisions, agency interactions, and historical responses are often trapped in email threads or lost between submissions.

Without governed workflows, audit trails, and version control, organisations increase the risk of compliance gaps, delays, and costly rework.

goPLIMS closes the gap

Five governed phases on one dedicated pharma cloud — from submission planning through document review, dossier gap analysis, agency queries, and knowledge retention. Small and mid-size teams get enterprise-grade submission governance without enterprise implementation complexity or cost.

One governed platform — real-time, compliant, built for pharma regulatory submissions

Governed Workflow

Five phases governing your regulatory submission end-to-end

Designed with input from senior QA and regulatory consultants — goPLIMS maps to how regulatory affairs teams actually work, governing each phase with the right modules from ActionR and RFI-M through TrackR, EDocM, ESignM, FormM, and DecisionM.

Pharma-specific use cases

Real regulatory submission scenarios governed by goPLIMS

From first-in-class NDA to parallel multi-market filings — goPLIMS is configured for the real complexity that small and mid-size regulatory affairs teams face managing high-stakes submissions.

NDA · Parallel MAA

NDA to FDA with simultaneous MAA to EMA — managing document review status across both dossiers in real time

A mid-size biopharma manages parallel NDA and MAA on goPLIMS — separate CTD module trackers per market in TrackR, all documents version-controlled in EDocM, market-specific review chains in place, and a single dossier gap analysis per market showing readiness in real time. The regulatory director sees both submission statuses on one dashboard — no manual compilation from two separate Excel trackers.

ANDA Portfolio

Five ANDA submissions managed simultaneously — document review status and gap analysis across all products

A generic pharma regulatory team manages five concurrent ANDAs on goPLIMS — each as a separate workstream with its own document review status tracker and dossier gap analysis. The VP Regulatory Affairs monitors submission readiness across the full portfolio from one TrackR dashboard, with agency queries from the FDA managed in the central RFI-M register across all five submissions.

Agency Query Management

Managing Day 74 EMA List of Questions — governed response workflow across CMC, clinical, and regulatory

An EMA Day 74 List of Outstanding Issues requires coordinated responses from CMC, clinical pharmacology, and regulatory teams within a 6-month clock. goPLIMS governs each question as an RFI — assigned to the relevant author, reviewed by RA, approved with e-signature, and the final response package assembled in EDocM. The response history and all supporting documents are retained in the knowledge management phase for the next variation or renewal.

Knowledge Management

Building a searchable regulatory knowledge library across five years of NDA and variation submissions

A specialty pharma company captures every regulatory strategy decision, agency interaction rationale, and submission lesson in goPLIMS DecisionM across five years of NDA and post-approval variation submissions. When a new regulatory affairs lead joins, she searches the knowledge library for prior FDA interactions on the same active ingredient — retrieving the complete decision and response history immediately, rather than requesting file access from three former colleagues.

Platform modules

The goPLIMS modules across all five submission phases

Seven purpose-built modules — each serving a specific role across the five submission phases — on one dedicated, 21 CFR Part 11 compliant pharma cloud sharing one audit trail, document store, and access controls.

ActionR

Action Register Management

All submission planning actions — document assignments, milestone deliverables, review tasks, and team responsibilities — governed with owner, deadline, and real-time status. Every submission milestone is tracked, not assumed.

EDocM

Electronic Document Management

The governed submission document repository — version control, review chains, and approval workflows for every CTD section. All documents retained permanently for the knowledge management phase — accessible to future submission teams without file migration.

ESignM

Electronic Signature Management

21 CFR Part 11 and EU Annex 11 compliant electronic signatures confirming document approval at each stage of the dossier gap analysis — timestamped, tamper-evident records that confirm exactly what is formally approved versus in-progress, per market, per module.

RFI-M

RFI Management

Pre-submission information requests and post-submission agency queries both governed as formal RFIs — FDA, EMA, Health Canada questions assigned, responded, reviewed, and retained with a complete audit trail. The submission query register that regulators review at approval.

TrackR

Central Online Tracker

The real-time submission readiness dashboard — CTD module completion by market, document review and approval status, and phase 2 governance overview — updated automatically as documents progress through the workflow. The single source of truth replacing every Excel status tracker.

FormM

Form Management

Structured document authoring templates and forms — ensuring consistent document quality and completeness across CTD sections and authors. Documents authored in FormM feed directly into the Phase 2 review workflow and Phase 3 gap analysis status.

DecisionM

Decision Management

Every agency query response rationale and every regulatory strategy decision — market prioritisation, dossier scope, agency consultation outcome — captured with alternatives and reasoning in DecisionM. The knowledge management phase is powered by DecisionM: every future submission team inherits a complete, searchable record of what was decided and why, permanently retained on the platform.

Data Integrity & Security

Submission records that meet the standards health authorities apply at approval

Every document review, agency query response, and approval record in goPLIMS is governed by data integrity and security controls that meet the requirements FDA, EMA, and Health Canada expect when reviewing your submission or inspecting your regulatory operations.

Built to 21 CFR Part 11 standard e-signatures

Every document approval, review chain sign-off, and agency response confirmation is executed with a timestamped, intent-captured electronic signature meeting FDA and EMA requirements for authentic, non-repudiable submission records.

Tamper-evident submission audit trail

Every authoring, review, approval, and query response action is recorded in an immutable, timestamped audit trail. When a regulator asks who approved a document and when, the answer is in goPLIMS — complete, unalterable, and exportable on demand.

Role-based access control

Authors, reviewers, approvers, and regulatory leads each have precisely scoped access to the documents and actions relevant to their role — enforced by the platform, not by shared folder naming conventions or email trust.

Single-tenant dedicated pharma cloud

Your regulatory dossiers and agency correspondence are never co-mingled with other pharma companies or industries. A dedicated instance with dedicated storage meeting GMP data security requirements for pharmaceutical submission records.

Data encryption and permanent retention

All submission data encrypted at rest and in transit. Records retained permanently — supporting the knowledge management phase and ensuring submission history is available for post-approval inspections and lifecycle management submissions years later.

ALCOA+ on every submission record

All records Attributable, Legible, Contemporaneous, Original, and Accurate — enforced by system architecture at the point of authoring and approval, meeting the data integrity principles health authorities apply to regulated submission records.

Reports & Dashboards

From real-time dossier status to a complete regulatory knowledge archive

goPLIMS generates the reports your regulatory project managers, QA reviewers, and VP Regulatory Affairs need — and produces the archive the submission requires — automatically, as the team works through each of the five phases.

Submission Readiness Dashboard

Real-time CTD module completion per target market — approved, in review, in authoring, and not started — linked to Phase 2 document review status. Updated automatically as documents progress. The dashboard that replaces the manually compiled Excel status report.

Dossier Gap Analysis Report

Phase 3 output — a structured report comparing approved documents in EDocM against the required CTD structure per market, showing missing documents, documents in authoring, and documents pending final e-signed approval, with responsible author and target date for each gap.

Agency Query Register

Phase 4 output — all RFIs from FDA, EMA, and Health Canada with agency, question reference, owner, response status, deadline, and submission date. The live register regulators review when assessing the quality of your agency interaction record at approval.

Document Review & Approval Status Report

Phase 2 detailed report — all submission documents by CTD section, with current author, review status, approval status, version, and days-to-target. Filterable by market, by function, and by document type for submission manager oversight and QA review prioritisation.

Regulatory Knowledge Register

Phase 5 output — all decisions captured in DecisionM across the submission lifecycle, searchable by programme, market, and decision type. The institutional knowledge register that ensures every future submission team inherits the regulatory strategy decisions, not just the documents.

Submission Archive Export

A complete, structured export across all five phases — submission plan, approved documents, agency queries and responses, and knowledge register — formatted as an inspection-ready archive for the regulatory file and post-approval lifecycle management.

Why goPLIMS

Five governed phases — without enterprise RIMS complexity or cost

Enterprise regulatory information management systems take 12–18 months to implement. goPLIMS delivers the same five-phase submission governance — at a scale and implementation speed that works for teams of 2 to 20 regulatory professionals.

Single dedicated cloud

Regulatory dossiers and agency correspondence never shared with other companies or industries. Dedicated infrastructure meeting GMP data security requirements for pharmaceutical submission records throughout all five phases.

21 CFR Part 11 by design

Every document review, e-signature, and agency query response is compliant from the moment it is created — not prepared for compliance before filing. The audit trail builds automatically across all five phases.

One integrated platform

The same platform governing your audits, pre-manufacturing phases, and knowledge management — so submission documents and decisions are connected to the full pharma programme record, not isolated in a standalone RIMS.

Live in days, not months

Configured to your submission programme — your target markets, your CTD structure, your team roles — and productive from day one across all five phases. No 12-month implementation before your team gains visibility of the first dossier gap.

What Makes Us Unique?

Frequently asked questions

Your questions answered.

goPLIMS governs regulatory submissions across five phases: (1) Submission Planning — strategy, target markets, milestones, and team using ActionR and RFI-M; (2) Governing Document Review, Submission and Approval Status — real-time authoring, review, and approval tracking using TrackR and EDocM; (3) Document Gap Analysis for Dossier — CTD module completeness and gap identification using ESignM and FormM; (4) Agency Query Management — governed FDA, EMA, and Health Canada query responses using RFI-M and DecisionM; and (5) Knowledge Management — decision capture, lessons learned, and agency response library using DecisionM and EDocM.

Phase 2 — Governing Document Review, Submission and Approval Status — uses TrackR to provide a real-time dashboard of every document’s authoring, review, and approval status across the CTD structure, and EDocM to manage the document repository with version control and governed review chains. The submission manager always knows which documents are approved, which are in review, which are in authoring, and which are not yet started — for every target market simultaneously.

goPLIMS continuously compares approved documents in EDocM against the CTD module structure required for each target market. The Document Gap Analysis for Dossier phase uses ESignM to confirm which documents have received formal e-signed approval, and FormM to identify documents still in structured authoring. The gap analysis report shows exactly which CTD sections are complete, pending, and outstanding — updated in real time as documents progress through the workflow.

Yes. goPLIMS manages parallel submission programmes as separate workstreams on one platform — each with its own CTD module tracker, document register, and agency query log. The shared platform means your team has a single view of what is complete, what is outstanding, and what the readiness score is for each dossier against its submission deadline, without duplicating work across separate tools for each market.

The fifth phase captures every regulatory strategy decision, agency response rationale, and lesson learned in DecisionM — with the full reasoning, alternatives considered, and outcome recorded. All submission documents remain in EDocM permanently. When the next submission begins, the regulatory team can search and retrieve prior strategy decisions, agency query history, and dossier preparation lessons — building on institutional knowledge rather than starting from scratch.

Govern every phase of your regulatory submission

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