From lead candidate to IND-enabling studies
R&D Product Development
Govern your pharma R&D programme from lead selection through IND
From lead candidate identification through formulation development, pre-clinical studies, and IND/CTA preparation — one governed, 21 CFR Part 11 compliant platform replacing disconnected notebooks, emails, and shared drives.
Dedicated pharma cloud | Decision capture built-in | Purpose-built for pharma R&D
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21 CFR
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R&D programmes generate critical decisions and knowledge that never make it into a governed record
Development decisions — why this formulation, why this manufacturing route, why this clinical dose — are among the most important records in the regulatory dossier. But most pharma R&D teams capture them in emails, meeting minutes, and lab notebooks that are never linked to the regulatory record and rarely survive a team change.
When the CMC team starts building the IND or NDA, they spend weeks excavating the rationale from inboxes and shared drives. When scientists leave, their knowledge leaves with them. When a programme is deprioritised and then revived, the development history has to be reconstructed from scratch.
- Lab notebooks with no version control or search capability
- Email threads capturing decision rationale that becomes impossible to find
- Shared drives for study reports with no approval workflow
- Excel Gantt charts updated manually with no milestone governance
- Development knowledge that disappears when scientists move on
Decisions, documents, and development milestones captured in goPLIMS at the point of action — searchable, governed, and permanently retained. Every future programme stage and every regulatory submission starts from a complete, governed development record.
End-to-end governance from lead selection through IND filing
goPLIMS governs every stage of the product development programme — from first candidate selection through formulation, pre-clinical, IND-enabling studies, and IND/CTA dossier preparation — on one platform with a complete, traceable development record.
Real R&D programme scenarios governed by goPLIMS
From greenfield facility builds to equipment installations — goPLIMS is configured for the real-world governance complexity of GMP capital project delivery in pharma.
Small molecule
Oncology lead optimisation — governing candidate selection across three backup molecules
A clinical-stage oncology company manages lead selection, SAR decisions, and formulation development for three candidate molecules simultaneously in goPLIMS — with each molecule as a separate workstream, sharing the same platform and decision audit trail for the eventual NDA CMC section.
Biologics · CMC
Biologic drug substance development — from cell line selection through DS formulation and fill-finish
A biotech CMC team governs cell line selection decisions, upstream and downstream process development, formulation screening, and fill-finish process design in goPLIMS — capturing every process decision in DecisionM so the CMC development history is available to the tech transfer and regulatory teams from the start.
First-in-class
IND-enabling package for a first-in-class CNS compound — FDA and EMA parallel filing
A specialty pharma team manages the IND-enabling programme for a novel CNS compound — governing toxicology studies, pharmacokinetic data packages, and manufacturing summaries in goPLIMS — assembling the IND for FDA and CTA for EMA from documents already in EDocM with e-signed approvals, rather than manually collecting files across functions.
Platform technology
Managing five parallel drug candidates on the same delivery platform technology
A platform technology company runs five drug candidates through the same development process on one goPLIMS instance — platform-level decisions captured once and referenced across all programmes, while candidate-specific formulation and pre-clinical decisions are maintained in individual workstreams. Every candidate’s development history is governed and submission-ready.
The goPLIMS modules powering pharma R&D programme management
Six purpose-built modules working together on one dedicated, 21 CFR Part 11 compliant cloud — governing every stage of product development from candidate selection through IND filing and beyond.
ActionR
Action Management
Assign and track every development programme action — experiment actions, milestone deliverables, cross-functional coordination items — with owner accountability and real-time status across all parallel development workstreams.
EDocM
Electronic Document Management
A governed repository for all R&D documents — pre-clinical protocols, study reports, development reports, manufacturing process descriptions — version-controlled, searchable, and linked to approval workflows across the development programme.
ESignM
Electronic Signature Management
21 CFR Part 11 compliant electronic signatures on every study report approval, development report, and IND section — timestamped, tamper-evident, and exportable as part of the regulatory filing package.
DecisionM
Decision Management
Capture every lead selection, formulation, process, and clinical strategy decision — with rationale, alternatives, and outcome. The governed decision record that populates the CMC section of your regulatory dossier, built as you go.
TrackR
Central Online Tracker
A real-time R&D programme dashboard — milestones by programme, action completion status, IND readiness score — updated automatically as documents and decisions progress through the governed workflow.
FormM
Form Management
Govern pre-clinical study checksheets as structured electronic forms — version-controlled, signed with 21 CFR Part 11 compliant e-signatures, and linked to the IND document package in EDocM EDocM.
R&D records built to meet regulatory scrutiny from day one
Every development decision, study protocol, and report in goPLIMS is governed by data integrity controls that meet the standards health authorities apply — so your R&D records are submission-ready from the moment they are created, not reconstructed before filing.
21 CFR Part 11 e-signed qualification records
Every study protocol, development report, and IND section approval is signed with a timestamped, intent-captured electronic signature meeting FDA requirements — so regulatory records are authentic and non-repudiable from the point of generation.
Immutable audit trail on every development record
Every create, update, and review action on an R&D record is captured in a tamper-evident, timestamped audit trail — meeting the ALCOA+ requirements health authorities apply when reviewing development history during IND review or inspection.
Role-based access control
Scientists, CMC teams, pre-clinical leaders, and regulatory reviewers each see only what their role permits. Proprietary formulation or process records are restricted to the teams that need them — enforced by the platform, not by file permissions.
Single-tenant dedicated pharma cloud
Your compound data, formulation records, and development decisions are never co-mingled with other companies or industries. Dedicated storage and infrastructure meeting GMP data security requirements for pharmaceutical intellectual property.
Data encryption and permanent retention
All development data encrypted at rest and in transit. Development records retained permanently — available for regulatory review, inspection, or programme revival years after the initial development phase — meeting GMP record retention requirements.
ALCOA+ enforced at source
All R&D records Attributable, Legible, Contemporaneous, Original, and Accurate — enforced by system architecture at the point of capture. What is recorded in goPLIMS cannot be backdated, unattributed, or altered after the fact.
From real-time programme status to an IND-ready development record
goPLIMS gives programme directors, CMC leads, and regulatory teams the visibility they need — and produces the development record the submission team needs — automatically, as the programme runs.
R&D Programme Dashboard
Decision Register Export
IND Readiness Report
Pre-clinical Study Document Index
Cross-Programme Milestone Report
Programme Knowledge Handover Pack
Purpose-built for pharma R&D — not adapted from a generic tool
Most project management and document tools used in pharma R&D were not designed for pharmaceutical development governance. goPLIMS was — with 21 CFR Part 11 compliance, pharma data integrity, and regulatory submission readiness built into every module from the ground up.
Single dedicated cloud
Your compound data and development records are never shared with other companies. A dedicated deployment meeting GMP data security requirements for pharmaceutical intellectual property throughout development.
21 CFR Part 11 by design
Compliance is the architecture. Electronic records, e-signatures, and audit trails are built into every module — so development records are submission-ready from the moment they are created, not prepared for filing.
Connected to clinical & submission
R&D decisions and documents flow directly into clinical trial planning, tech transfer, and regulatory submission workstreams on the same platform — no handoff package to assemble, no files to migrate.
Live in days, not months
No lengthy implementation. Configured to your programme structure — your therapeutic areas, your development stages, your team roles — and productive from day one with onboarding support included.
Your questions answered.
goPLIMS supports unlimited parallel programmes and workstreams on one platform — each with its own milestone plan, document register, decision log, and team access. Programme directors get a cross-programme dashboard showing all development programmes simultaneously, while scientists see only the workstreams relevant to their role.
DecisionM captures every key development decision — lead candidate selection rationale, formulation approach, manufacturing process choices, clinical dose selection — with the alternatives considered and outcome recorded. This builds a structured, searchable decision record that feeds directly into the CMC section of the IND or NDA and is available to the regulatory submission team from day one of development.
Yes. IND-enabling pre-clinical study plans, protocols, and reports are governed in EDocM with version control and a review-and-approval workflow — each document signed with a 21 CFR Part 11 compliant e-signature. The IND document package is assembled from approved documents already in the platform, with no need to collect files from shared drives or email inboxes before submission.
Yes. goPLIMS governs the full pre-manufacturing journey on one platform — the R&D programme feeds directly into clinical trial planning, with decisions, documents, and programme knowledge shared across phases. When the submission team begins IND or NDA preparation, the development history, CMC decisions, and pre-clinical documentation are already in EDocM and DecisionM — not in a scientist’s local drive.
Ready to govern your pharma R&D programme from lead selection through IND?
See how goPLIMS replaces disconnected R&D tools with one governed, compliant platform — purpose-built for pharma product development teams.