Regulatory Submission Readiness
Govern Regulatory Submissions
Govern every phase of your regulatory submission
Regulatory submission teams are managing high-stakes submission programmes using Excel trackers, email chains, and shared drives — tools with no audit trail, no governed workflow, and no real-time dossier visibility. goPLIMS changes that.
Dedicated pharma cloud | Built for small & mid-size teams
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21 CFR
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Pharma teams are managing high-stakes submissions with tools built for none of this
An NDA or MAA submission is one of the most complex, high-stakes projects a pharma company undertakes. It involves hundreds of documents, multiple authors across functions, agency queries demanding precise responses on tight deadlines, and a dossier that must be complete, consistent, and defensible on the day of submission.
Most regulatory teams manage all of this with Excel trackers manually updated, email chains with no audit trail, and shared drives with no version control. There is no cross-functional collaboration and real-time visibility of what is complete, what is outstanding, and what gaps exist in the dossier right now.
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- Excel CTD module tracker — manually updated, version confusion
- Email chains to coordinate authors, reviewers, and approvers
- Shared drives for documents with no review workflow or audit trail
- Separate tools for agency queries, documents, and milestones
Submission knowledge and agency response history lost between submissions
A purpose-built, dedicated cloud platform that gives regulatory teams governed workflows, real-time dossier readiness dashboards, and 21 CFR Part 11 compliant records — without the implementation cost or complexity of enterprise RIMS
One governed platform — real-time, compliant, purpose-built for teams collaboration and seamless integration
End-to-end governance across your regulatory submission lifecycle
goPLIMS governs every phase of the regulatory submission process — from submission strategy and planning through document authoring, review and approval, dossier gap analysis, agency query management, and post-submission knowledge retention.
Real regulatory submission scenarios governed by goPLIMS
From first-in-class NDA to parallel multi-market submissions — goPLIMS is configured for the real-world complexity that regulatory affairs teams face.
New drug application
NDA submission to FDA for a novel small molecule — parallel MAA to EMA
A biopharma company manages simultaneous NDA and MAA preparation on goPLIMS — separate CTD module trackers per market, shared document authoring with market-specific adaptations, and a single agency query register tracking FDA and EMA RFIs from Day 74 through approval.
Generic drug submission
ANDA programme management for a portfolio of five generic drug products
A generic pharma regulatory team uses goPLIMS to manage five concurrent ANDA submissions — each as a separate workstream with its own CTD tracker, bioequivalence documentation register, and FDA query log — with a cross-submission dashboard showing portfolio readiness at a glance for the VP of Regulatory Affairs.
Clinical trial authorisation
IND and CTA filing for first-in-human Phase I study — US and EU sites
A clinical-stage biotech manages IND preparation for the FDA and CTA preparation for EMA in goPLIMS — governing protocol documents, investigator brochure versions, manufacturing section, and clinical pharmacology modules across both filings with a single team and shared document repository.
Post-approval management
Managing a portfolio of post-approval supplements & variations across multiple markets
A mature product regulatory affairs team tracks CMC supplements to FDA, Type IA/IB/II variations to EMA, and notifiable change submissions to Health Canada in goPLIMS — with each variation as a governed workstream, its own document package, agency query log, and approval milestone — all visible on one dashboard.
Powering Regulatory Submission Readiness
Six purpose-built modules working together on one dedicated, 21 CFR Part 11 compliant cloud — from submission planning through agency query management and post-submission knowledge retention.
ActionR
Action Register Management
Assign and track every submission milestone and document action — author assignments, review actions, approval tasks, and post-submission commitments — with owner accountability and deadline management across all markets.
EDocM
Electronic Document Management
A single governed repository for every submission document — CTD modules, clinical study reports, manufacturing summaries, labelling — version-controlled, linked to the approval workflow, and searchable across submissions.
ESignM
Electronic Signature Management
21 CFR Part 11 and EU Annex 11 compliant electronic signatures on every document approval, submission cover letter, and regulatory commitment — timestamped, tamper-evident, and exportable for inspection.
RFI-M
RFI Management
Manage agency queries from FDA, EMA, and Health Canada as governed RFIs — with owner assignment, response deadlines, review and approval before submission, and a complete query history retained across submissions.
TrackR
Central Online Tracker
A real-time submission readiness dashboard — CTD module completion by market, document authoring status, outstanding reviews, and overdue actions — replacing the manually updated Excel tracker your team currently lives in.
DecisionM
Decision Management
Capture every submission strategy decision — market prioritisation, dossier scope choices, agency consultation outcomes — so the regulatory strategy is retained in the platform and available to every future submission team.
Regulatory submission records that meet health authorities apply
Every document, approval, and agency response managed in goPLIMS is governed by data integrity and security controls that meet the requirements FDA, EMA, and Health Canada expect to see when they review your submission or inspect your organisation.
21 CFR Part 11 compliant e-signatures
Every document approval and submission cover letter is signed with a timestamped, intent-captured electronic signature — meeting FDA requirements for authenticity and non-repudiation on all submission records.
Tamper-evident submission audit trail
Every authoring, review, approval, and submission action is captured in an immutable, timestamped audit trail. When an inspector asks who approved a document and when, the answer is in the platform — complete and unalterable.
Role-based access and document security
Authors, reviewers, approvers, and regulatory leads each have precisely scoped access. Submission documents are not accessible to those without appropriate role permissions — enforced by the platform, not by folder naming conventions.
Single-tenant dedicated pharma cloud
Your regulatory submissions — dossier documents, agency query responses, strategic decisions — are never co-mingled with other companies or industries. Dedicated storage and infrastructure meeting GMP data security requirements.
Data encryption and disaster recovery
All submission data is encrypted at rest and in transit. Automated backup and point-in-time recovery ensures your regulatory records are always available — meeting the data availability requirements applicable to submission management systems.
ALCOA+ enforced at every action
Submission records are Attributable, Legible, Contemporaneous, Original, and Accurate — the ALCOA+ principles health authorities apply to GMP data are enforced by goPLIMS architecture on every regulatory submission record.
From real-time dossier readiness to a complete agency query register
goPLIMS gives your regulatory team — and your leadership — the visibility they need to manage high-stakes submissions without manually compiling status updates from across the team.
Dossier Gap Analysis Report
Agency Query Register
Submission Readiness Dashboard
Document Authoring Status Report
Parallel Submission Status Report
Submission Archive Export
Built for regulatory teams — not enterprise RIMS
Enterprise regulatory information management systems take 12–18 months to implement and cost more than most small and mid-size pharma teams can justify. goPLIMS delivers the same governance for submission management — at a scale and price that works.
Single dedicated cloud
Your regulatory dossiers are never shared with other companies or industries. A dedicated deployment meeting GMP data integrity and data security requirements for submission records.
21 CFR Part 11 by design
Compliance is the architecture, not a feature. Electronic records, e-signatures, and audit trails are built into every module from the ground up — not bolted on after the fact.
One integrated platform
The same platform that governs your audits, pre-manufacturing phases, and knowledge management — sharing one audit trail, document store, and dedicated cloud across all programmes.
Live in days, not months
No 12-month RIMS implementation. goPLIMS is configured to your submission programme and productive from day one — with onboarding support included for your regulatory team.
Your questions answered.
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 readiness score each dossier has against its submission deadline, without duplicating work across separate tools for each market.
Every agency query is managed as a governed RFI in RFI-M — assigned to an owner, given a response deadline, reviewed and approved before submission, and retained as a permanent record on the platform. The agency query register gives submission managers a real-time view of all open queries, response status, and overdue items across all submissions.
goPLIMS supports NDA, BLA, MAA, ANDA, IND, and CTA submissions — as well as post-approval supplements, variations, and lifecycle management submissions. Each submission type is configured with the relevant CTD module structure, document types, and review workflow appropriate to the regulatory pathway and target market.
Yes — goPLIMS was specifically designed for small and mid-size pharma teams managing high-stakes submission programmes without the resources to implement enterprise regulatory information management systems. The platform is priced, implemented, and supported at a scale that works for teams of 2 to 20 regulatory professionals, and can be live within days of configuration.
Ready to govern your next regulatory submission?
See how goPLIMS replaces Excel trackers and email chains with one compliant, governed submission platform — purpose-built for small and mid-size pharma regulatory affairs teams.