One regulatory record. Every product. Every market.
Custom Regulatory Information Management platforms for pharma, biotech, and medical device companies — products, dossiers, submissions, health-authority correspondence, and commitments unified in one connected record, with live portfolio visibility for RegOps and leadership. Built around your operations, designed to coexist with the systems you already run, and rolled out one product family or therapeutic area at a time.
Product, Substance & Dossier Registry
One identity record per product and substance, linked to dossiers, variations, indications, and active registrations — engineered with awareness of IDMP and xEVMPD identity concepts so your data model can carry forward as global standards evolve.
Submission Planning & Lifecycle Tracking
Submission plans, milestones, content tracking, and status views aligned with eCTD lifecycle structure (original, supplement, amendment, response, annual report) — so planners, authors, and leadership are looking at the same submission state, in real time.
Registration & Market Tracking
Active registrations, approval status, validity dates, and renewal obligations tracked per product, per market, per health authority — surfacing risk on registrations approaching expiry, well before a market access surprise.
Health-Authority Correspondence
Inbound questions, deficiency letters, meeting requests, and outbound responses logged against the dossier and submission they belong to — so the history of every conversation with FDA, EMA, or any other authority lives with the record, not in inboxes.
Commitments & Obligation Tracking
Post-approval commitments, label updates, post-marketing studies, and pharmacovigilance obligations tracked with owner, due date, status, and audit history — so commitments to authorities are visible and actionable, not buried in shared drives.
Controlled Records & e-Signature Workflows
Electronic records, e-signature workflows, and controlled vocabularies engineered with awareness of 21 CFR Part 11 expectations — attributable, contemporaneous, original, accurate, and reviewable — sitting underneath everything else on the platform.
One Record. Every Product. Every Market.
Product, dossier, registration, correspondence, and commitment data tied to one connected record per product — so RegOps, RegAffairs, QA, and leadership all see the same state, at the same time, for every market you operate in.
Workflows That Fit How RegOps Runs
Submission planning, authoring intake, publishing handoff, correspondence logging, and commitments tracking configured to your SOPs — with controlled vocabularies, electronic-record discipline, and a clean chain of changes already in place for your reviewers.
Engineered with audit-trail, e-signature, and controlled-vocabulary awareness for life-sciences regulatory work
Audit Trail That Carries Your Regulatory Work
We engineer the RIM platform so audit logging, chain-of-changes, and approval gates are first-class features against every regulatory event — record created, document attached, status changed, e-signature applied, correspondence logged, commitment closed. Your QA function executes the validation; the platform supplies the engineering evidence.
Controlled Vocabularies & Lineage That Support Your Reviewers
Schema-level lineage, controlled vocabularies across products, indications, submission types, and authorities, immutable audit records, and database-level constraints — making product, dossier, submission, correspondence, and commitment data traceable for your QA, audit, and authority-readiness reviewers.
Electronic Records & e-Signature, 21 CFR Part 11–Aware
Electronic records and e-signature workflows engineered with awareness of 21 CFR Part 11 expectations — attributable, contemporaneous, original, accurate, and reviewable. Predicate-rule decisions, submission decisions, and any health-authority interaction stay with your regulatory and QA leadership.
One regulatory record. Every product. Every market.
Products and substances, dossiers and variations, submissions, health-authority correspondence, and commitments — bound together by one connected record, on a shared engineering foundation built for unification, live visibility, audit-aware data, and non-disruptive coexistence with the systems you already run.
Products & Substances
IDMP-aware identity across your portfolio.
Dossiers & Variations
ICH M4-aligned structure, lifecycle aware.
Submissions
eCTD lifecycle planning and status tracking.
Correspondence
Health-authority questions and responses, logged.
Commitments
Post-approval obligations with owners and dates.
Unified data, live visibility, audit-aware engineering & coexistence — by design
- Unified data model — products, dossiers, submissions, correspondence, commitments
- Live visibility — submission state, registration risk, commitment deadlines
- Audit-aware engineering — chain of changes, e-signature, controlled vocabularies
- Coexistence-first — APIs your IT team controls, no rip-and-replace
Compliance by design
Engineering artifacts for your validation work
We structure the build so your QA team has the documentation, traceability, and test evidence they need to execute their own IQ/OQ/PQ and validation work. We do not author validation protocols, perform validation, or sign off on validation on your behalf.
Audit-trail logging as an engineering default
Every regulatory event — record created, document attached, status changed, e-signature applied, correspondence logged, commitment closed — is captured with actor, timestamp, action, and outcome. Audit records are immutable at the database layer so your reviewers can read a continuous chain of changes against every dossier, submission, and commitment.
Electronic records & e-signature awareness
Electronic records and e-signature workflows engineered with awareness of 21 CFR Part 11 expectations — attributable, contemporaneous, original, accurate, and reviewable. Predicate-rule decisions, submission decisions, and any health-authority interaction stay with your regulatory and QA leadership.
Controlled vocabularies across regulatory data
Products, indications, substances, submission types, authority identifiers, and document categories are managed through controlled vocabularies — so the same product, the same dossier, and the same authority are referenced the same way everywhere on the platform, by every user, on every report.
Identity & role-scoped access
Standards-based identity with enforced MFA, role-scoped access for regulatory operations, regulatory affairs, QA, leadership, and admin populations, and least-privilege defaults across modules and APIs.
Cloud infrastructure for regulated environments
Hosted on cloud regions and configurations commonly used for sensitive regulatory data, with private endpoints, infrastructure defined and reviewed via Terraform, and environment promotion gates your team can sign.
Audit-ready on day one
Every component of the RIM platform is engineered with audit-trail logging, electronic-record and e-signature awareness, role-scoped access, controlled vocabularies, and lifecycle artifacts your QA, regulatory, and IT teams can use as inputs into their own validation, audit, and authority-readiness work. Validation execution, IQ/OQ/PQ authoring, any regulatory submission, any health-authority interaction, any product registration decision, and any approval-pathway outcome remain solely the customer's responsibility, executed by the customer's regulatory operations, regulatory affairs, and QA functions. Sorento Software does not represent, certify, attest, or warrant compliance with any regulatory framework on behalf of any customer, does not file submissions or correspond with health authorities on a customer's behalf, and does not provide regulatory or legal advice.
Partner agreements in place
A Single Regulatory Record of Truth
Products, dossiers, submissions, registrations, correspondence, and commitments stop living in five different tools and one twenty-tab spreadsheet. One connected record, one place to look, one number that everyone — RegOps, RegAffairs, QA, leadership — is acting on.
Live Visibility Across the Regulatory Portfolio
Submission state, registrations approaching expiry, commitments coming due, and recent health-authority correspondence — surfaced live on dashboards your RegOps team and leadership share, so surprises stop arriving as renewal letters and missed deadlines.
Faster, Cleaner Submission Operations
Submission plans, content tracking, and status views configured to your eCTD lifecycle and your SOPs — removing the manual status calls, the "where are we?" emails, and the rekeying that throttle your team between authoring, publishing, and submission.
Configurable to Your Operations — Not a Vendor Template
Your product taxonomy, your submission types, your status states, your reporting formats. Workflows, fields, controlled vocabularies, and approvals are configured to the way your regulatory team actually works — without forcing your SOPs into someone else's product shape.
No Rip-and-Replace of Your Validated Stack
The RIM platform is designed to coexist with the EDMS, publishing, safety, quality, and clinical systems you have already validated — your IT and integration teams own the actual connectors, so existing validation work is preserved and adoption can be phased.
Audit-Ready Data Your QA Team Can Stand Behind
The same engineering that gives RegOps visibility gives QA and authorities a clean chain of changes — every regulatory event captured with actor, timestamp, action, and outcome, and electronic-record workflows engineered with awareness of 21 CFR Part 11 expectations.
Our Implementation Process
Discovery, Information Mapping & Engineering Framing
We walk your regulatory operations — submission planning, authoring intake, publishing handoff, correspondence logging, commitment tracking, registration upkeep — inventory the systems your team is using today (including the spreadsheets and shared drives), identify the audit-trail and controlled-vocabulary gaps, and frame the engineering shape before scoping the build. Validation strategy and any submission decisions stay with your QA and regulatory leadership.
Architecture & Engineering Plan
Design the RIM architecture, product and dossier data model, submission lifecycle states, correspondence and commitment structures, audit-trail and e-signature design, role-scoped access posture, and reporting layer alongside your IT, security, and QA stakeholders. Framework expectations (21 CFR Part 11, eCTD lifecycle structure, IDMP and xEVMPD concepts, GxP umbrella, HIPAA where applicable) are built into the engineering plan as design awareness — not certification claims.
Build & Iterate
Iterative full-stack development of the RIM platform — product and dossier registry, submission planning, registration and market tracking, correspondence, commitments, and admin tooling — with engineering artifacts (test coverage, validation-support evidence, change logs) captured as part of the build. Sprint demos with regulatory operations and regulatory affairs keep the platform anchored to real submission work.
Integration & Handoff to Your QA / Validation Function
Connect to your existing publishing, EDMS, safety, quality, and clinical systems via documented APIs and standard data formats your IT team controls — no proprietary connectors, no vendor lock-in. Run UAT with your regulatory operations, regulatory affairs, and quality stakeholders, and assemble the engineering documentation set your QA team uses as inputs into their own IQ/OQ/PQ work. We do not author validation protocols or perform validation on your behalf.
Phased Go-Live, Hypercare & Lifecycle Operations
Phased go-live by product family, therapeutic area, or market region so submissions and registrations already in flight are never disrupted while your team migrates onto the new platform. An initial hypercare period covers monitoring, defect triage, change-control reviews, and tuning so the platform stays in a known state as your portfolio, regulations, and operating model evolve.
Where Sorento Software fits
We are an engineering services firm for the regulatory operations and regulatory affairs teams of pharma, biotech, and medical device companies. We bring deep engineering competence in audit-aware data models, electronic-record and e-signature workflows, controlled vocabularies, and submission-lifecycle structure — and the discipline to make the platform we build something your QA function and authorities can stand behind.
We work alongside your regulatory operations, regulatory affairs, QA, IT, and external auditors. The submissions, the health-authority relationships, the validation execution, and the regulatory exposure belong to our client. We bring the engineering.
- We do not file submissions to FDA, EMA, or any health authority on a customer's behalf.
- We do not author or own regulatory submissions, dossiers, labels, or responses to health-authority queries.
- We do not perform validation, IQ/OQ/PQ, or computer-system validation on a customer's behalf.
- We do not provide regulatory or legal advice; clients retain their own regulatory affairs leadership, QA, and legal counsel.
- We do not classify medical devices or determine submission pathways (510(k), De Novo, PMA, NDA, BLA, ANDA, MAA, etc.).
- We do not provide audit, attestation, or certification against 21 CFR Part 11, ICH, IDMP, or any other regulatory framework — we engineer with awareness of those frameworks alongside the client's QA team and external auditors.
Frequently Asked Questions
Are you offering a packaged, validated RIM platform, or a custom build?
We are a software engineering partner that builds custom RIM platforms around your regulatory operations — your product taxonomy, your submission types, your status states, your reporting formats, your SOPs. We do not sell a packaged, pre-validated RIM product, and we do not perform validation, IQ/OQ/PQ authoring, or health-authority submission on your behalf. What we deliver is the platform plus engineering artifacts your QA and regulatory teams use as inputs into their own validation work — audit logs, configuration history, change-control records, and documentation.
How does the RIM platform fit alongside our existing EDMS, publishing, safety, and clinical systems?
The platform is designed to coexist with the document management, submission publishing, safety, quality, and clinical systems you already run — using documented APIs and standard data exchange formats. Your IT and integration teams own the actual connectors into your validated stack, so existing validation work is preserved. We do not claim partnerships, certifications, or pre-built integrations with any third-party RIM, EDMS, publishing, or safety vendor; we build the engineering surface your team uses to integrate.
How does the platform address eCTD lifecycle, IDMP, and xEVMPD?
The data model is engineered with awareness of eCTD lifecycle structure (original, supplement, amendment, response, annual report) and IDMP / xEVMPD identity concepts so that products, substances, dossiers, and submissions can be represented in a way your team can carry forward as global standards evolve. We engineer the data model and the workflows; submission compilation, dispatch, and any health-authority interaction remain with your regulatory operations function and any publishing tool your team operates.
Can we roll the RIM platform out by product family or therapeutic area instead of a single cutover?
Yes — this is the default approach, not an option. Single "big bang" cutovers are one of the most common failure modes in RIM programs, and we design against them. The platform is built so one product family, one therapeutic area, or one market region can go live independently, with clear data and integration boundaries. This lets you prove operational fit on one slice of the portfolio, train your team incrementally, and expand the rollout without disrupting submissions already in flight.
How does the platform handle audit trail, electronic records, and 21 CFR Part 11?
Every regulatory event — record created, document attached, status changed, e-signature applied, correspondence logged, commitment closed — is logged with actor, timestamp, action, and outcome; audit records are immutable at the database layer; and electronic-record and e-signature workflows are engineered with awareness of 21 CFR Part 11 expectations — attributable, contemporaneous, original, accurate, and reviewable. Predicate-rule decisions, validation execution, and any authority interaction remain with your regulatory and QA leadership. We make no compliance certification on your behalf.
What does a typical engagement look like, and how do you scope it?
Engagement scope, timeline, and investment vary by portfolio and operating model and are defined during discovery — we do not quote fixed durations or fixed regulatory outcomes on a public page. Discovery is where we map your regulatory operations, inventory the systems and spreadsheets your team is using today, identify the highest-leverage areas, and frame the engineering and integration shape before any production-bound code is written. The build is typically phased so the highest-priority product family or therapeutic area goes live first and your team can review the platform before later phases land.
Looking for a RIM platform that fits your regulatory team?
Book a free 30-minute discovery call. We will walk through your regulatory operations, the systems and spreadsheets your team is using today, and the engineering shape of a custom RIM platform — and outline a realistic, phased scope. Validation, submission, and any health-authority interaction remain with your team.