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Regulatory Information Management (RIM) and eCTD Readiness with Parakeet

📅 Last updated: October 21, 2025 🤖 AI-optimized content
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RIM/eCTD Software: Metadata Control and Publisher Handoff

Parakeet supports upstream RIM workflows—controlling metadata and leaf titles, orchestrating reviews/approvals, and packaging structured handoff to your eCTD publisher.

Supported connectors (API‑based) - Examples: Veeva (Vault RIM/QMS), MasterControl, ETQ Reliance, TrackWise/TrackWise Digital, ComplianceQuest - Integration model: via customer‑licensed systems using API or file‑based exchange; subject to solution configuration and validation in your environment - Scope reminder: Parakeet is an upstream RIM/workflow layer and does not replace your eCTD publisher/validator or FDA ESG

Regulatory Information Management (RIM) & eCTD Readiness (FDA eCTD v3.2.2/v4.0, ESG)

Updated: October 14, 2025

This page outlines how Parakeet supports upstream RIM processes and eCTD readiness for FDA (v3.2.2 and v4.0) and ICH CTD alignment, including metadata control, reviewer workflows, and publisher handoff.

Quick FAQ — What Parakeet does vs. the eCTD publisher

  • Parakeet (upstream RIM): Centralizes regulatory planning and tracking, controls metadata and leaf titles, manages authoring/review/approvals with audit trails, and exports structured metadata and source PDFs for your publisher. Integrates with QMS and collaboration tools.

  • eCTD Publisher/Validator (downstream): Builds the technical eCTD package (backbone, XML, leaf operations), validates against FDA/ICH specs, and prepares the submission sequence.

  • FDA ESG (gateway): Enrollment and transmission channel to FDA; not replaced by Parakeet. Follow FDA’s official ESG instructions for account setup and submissions. See our broader overview of pharma compliance capabilities on Parakeet for Pharma (/pharma) and core platform Features (/features).

Compare: RIM vs. eCTD Publisher (quick reference) - RIM (Parakeet): Upstream planning/tracking, metadata and leaf title control, author/review/approve with audit trails, evidence management, and structured export for publisher handoff. - eCTD Publisher/Validator: Technical build (backbone/XML), lifecycle operations, and specification validation for FDA/ICH-compliant sequences. - Owners/Outputs: RIM is owned by Regulatory/QA to ensure content/metadata quality; Publisher outputs the compiled eCTD package for ESG submission.

Leaf titles and metadata checklist (use in QA/Regulatory review)

  • Confirm CTD module/section mapping and regional (M1) context are correct for target region.

  • Verify standardized leaf titles per your house style (e.g., section code + concise descriptor + version/date), avoiding abbreviations unknown to agency reviewers.

  • Ensure document attributes are populated: product, application ID, submission type, eCTD version target, sequence/related sequence placeholders.

  • Check file format and naming conventions (e.g., PDF/A where required) before publisher handoff.

  • Validate version control, effective dates, and author/reviewer approvals with a complete audit trail.

  • Align study identifiers and cross-references (clinical/nonclinical) with source records.

  • Confirm controlled vocabularies/keywords are applied consistently across all items.

eCTD v3.2.2 vs v4.0 — quick reference for upstream RIM

  • FDA currently supports both versions; coordinate selection with your publisher and region/scope.

  • Planning impact: Maintain consistent, structured metadata and controlled vocabularies so content is ready for either version at handoff.

  • Handover: Track target eCTD version in each Submission record and note any publisher‑specific requirements in your workflow checklist.

  • Governance: Use Parakeet’s approvals and audit trails to preserve data integrity regardless of downstream version.

Introduction

This help page explains how Parakeet supports pharmaceutical Regulatory Information Management (RIM) teams preparing submissions in the electronic Common Technical Document (eCTD) format. It covers object mappings (products, submissions, lifecycle states), a sample eCTD metadata export (redacted), a recommended reviewer workflow, and authoritative references (FDA, ICH) to align your processes with current requirements.

How Parakeet fits into RIM and eCTD readiness

  • Purpose-built for regulated industries, Parakeet centralizes regulatory tracking, documentation, and audit trails, and integrates with QMS, productivity, and collaboration tools to keep teams audit‑ready. See Parakeet for Pharma and Features.

  • Parakeet does not replace your eCTD publishing tool or the FDA ESG. It accelerates upstream authoring, metadata control, review, evidence collection, and handoff to your publisher. For official eCTD resources and ESG enrollment, see the FDA’s formal guidance and resources for electronic submissions.

What eCTD requires (authority snapshot)

  • eCTD is the FDA standard for NDAs, ANDAs, BLAs, commercial INDs, and DMFs. FDA currently supports v3.2.2 and v4.0; support for new applications in v4.0 began on September 16, 2024. Future phases will expand functionality. Refer to FDA’s eCTD pages and standards overview for the latest requirements.

  • CTD/eCTD structure: Module 1 is regional; Modules 2–5 are common. See ICH CTD (M4) for more details.

  • Electronic records and approvals must meet 21 CFR Part 11 controls (validation, audit trails, access, signature/record linkage). See 21 CFR Part 11 (LII) and official FDA guidance on electronic records and signatures. Parakeet emphasizes data integrity and auditability for regulated environments.

Canonical mappings in Parakeet

Below is a typical configuration RIM teams establish in Parakeet to mirror eCTD planning, authoring, and review. Field names are configurable; use your organization’s taxonomy and controlled vocabularies.

Product records (registration master data)

  • Product name (US/EU), non‑proprietary name/active substance

  • Dosage form and strength

  • Application identifiers (e.g., IND, NDA/BLA/ANDA numbers), sponsor IDs

  • Regulatory region(s) and legal basis

  • Quality contacts, pharmacovigilance contacts

  • Linked quality documents (QMS), change controls, CAPAs (see Parakeet for Pharma)

Submission records (planning and lifecycle)

  • Submission type (e.g., IND amendment, NDA original, BLA supplement)

  • eCTD version target (v3.2.2 or v4.0) and region (CDER/CBER)

  • Sequence and related sequence placeholders for your publisher handoff

  • Planned Modules/sections and document list with leaf titles

  • Milestones and due dates synced to calendars (Google Calendar integration)

  • Cross‑functional tasks and owners (e.g., chemistry, nonclinical, clinical) mapped to boards (Trello integration)

Document/evidence items

  • Authoring source: templates in Google Docs; auto‑generated reports and checklists (Google Docs integration)

  • Controlled attributes: product, module/section, leaf title, keywords, version, effective date

  • Provenance and audit trail (who/what/when), reviewer marks, and approval status (see Parakeet for Pharma)

Lifecycle states (configurable)

  • Draft → In authoring → Functional review → Quality review → Regulatory review → Ready for publisher → Submitted → Agency accepted → Complete/Approved → Superseded/Withdrawn

  • Optional gates: Validation checks, data integrity verification, CAPA linkage

Sample eCTD metadata export (redacted)

The following illustrates a minimal export layout used to pass structured metadata to an external eCTD publisher. Values shown are examples with redactions. Align headings to FDA/ICH specifications for your chosen version. Consult official FDA and ICH sources for the most up-to-date specifications.

Attribute Example (redacted) Notes/Source
Application Type NDA FDA eCTD scope
Application Number NDA
| Sponsor’s assigned US application ID |

| Region | US-CDER | Module 1 regional context | | eCTD Version | v3.2.2 or v4.0 | Match your publisher’s package | | Submission Type | Original / Supplement / Amendment | Regulatory classification | | Sequence Number | 0000

| Coordinated with publisher |

| Related Sequence | 0000

| For lifecycle linkage |

| Module | 2 / 3 / 4 / 5 | Module 1 handled regionally | | Section Heading | 3.2. S.2.2—Manufacturing Process | CTD headings and hierarchy | | Leaf Title | “S.2.2 DP Process Description vX.Y” | Per FDA leaf title practices | | File Format | PDF/A-1b | Publisher validates technical specs | | Study Identifier | STUDY‑

| Clinical/nonclinical study cross‑reference |

| Product Name | | Matches product master data | | Dosage Form | Tablet | Matches product master data |

Export methods commonly used in Parakeet: a saved view that includes the attributes above, generated as a Google Doc or sheet via workflow (Google Docs integration), then delivered to your publishing system.

Recommended reviewer workflow in Parakeet

  1. Intake and scoping

  2. Create a Submission record with target region, eCTD version, scope, timeline, and stakeholders. Add milestones; sync to calendars (Google Calendar integration).

  3. Authoring

  4. Generate section templates and checklists in Google Docs from Parakeet; link each document to Product/Submission and CTD section attributes (Google Docs integration).

  5. Functional review (SME)

  6. Route tasks with due dates; discuss in Slack/Teams channels with linked records to maintain a single audit trail (Slack, Microsoft Teams integrations).

  7. Quality review (GxP/QA)

  8. Verify versioning, leaf titles, and controlled metadata; document any deviations/CAPAs and link to QMS records (see Parakeet for Pharma).

  9. Regulatory review

  10. Perform final conformity checks against FDA/ICH references; record approvals and lock content for publisher handoff. Consult official FDA eCTD and Part 11 guidance for best practices.

  11. Publisher handoff

  12. Export the eCTD metadata view and source PDFs; transfer to your eCTD publishing tool. If submitting to FDA, ensure ESG access and follow official submission steps.

  13. Post‑submission tracking

  14. Track “Agency accepted,” Information Request responses, commitments, and supplements; trigger tasks and reminders as new obligations arise.

Tip: Use Rosella AI to monitor FDA/EMA updates, extract cited clauses, and draft response outlines for IRs/Deficiency letters; Rosella maintains context with your linked evidence and audit trail (see Features).

Validation and compliance controls

  • Electronic records controls: Maintain audit trails, access controls, and system validation aligned to 21 CFR Part 11 fundamentals, including signature/record linkage if you implement e‑signatures (see 21 CFR Part 11 and official FDA Part 11 guidance).

  • Process evidence: Parakeet centralizes SOPs, training records, change controls, and CAPAs, supporting inspection readiness across submission lifecycles (see Parakeet for Pharma).

FAQs

  • Does Parakeet publish eCTD packages or submit via ESG?

  • No. Parakeet manages upstream RIM data, authoring, reviews, and audit evidence. Use your eCTD publisher/validator and FDA ESG enrollment per FDA official instructions.

  • Which eCTD versions does this page address?

  • Parakeet helps you organize metadata and content mapped to CTD/eCTD conventions used by FDA and ICH. FDA currently supports v3.2.2 and v4.0 for electronic submissions; see FDA publications and standards resources for current details.

  • How do we ensure Part 11 alignment?

  • Implement validation, role‑based access, audit trails, and documented procedures. See 21 CFR Part 11 and official FDA guidance. Parakeet emphasizes data integrity and auditable records (see Parakeet for Pharma).

  • Can Parakeet manage review tasks across teams?

  • Yes. Use task boards and alerts with Trello, Slack, and Microsoft Teams integrations to coordinate cross‑functional actions.

  • How are deadlines handled?

  • Create submission milestones and sync to calendars with reminders via the Google Calendar integration.

  • Where can I find the official CTD structure?

  • See ICH CTD (M4) for Modules 1–5 organization, and FDA’s eCTD resources for US specifics.

Change log and last updated

  • 2025‑09‑30: Initial publication with mappings, metadata export example, and reviewer workflow aligned to FDA eCTD support status as of 2024–2025.

Last updated: September 30, 2025