Slow and expensive
Generic and hybrid applications repeat the same work: adapting reference product information, filing documents into CTD sections, and checking that nothing is missing before submission.
Regulatory AI · Built in Oxford
Regulatory submissions, prepared in days, not weeks.
Oxford Expert is an AI workbench for regulatory affairs teams. It drafts SmPCs and patient leaflets, assembles CTD dossiers, checks them for gaps and translates them, and every result goes to a qualified expert for review and sign-off.
SmPC/PIL AI editor with the UK/MHRA rule set. Product data shown is a demo.
01 · The problem
Regulatory documentation is still assembled by hand
A marketing authorisation dossier runs to hundreds of documents across five CTD modules, in several formats and often several languages. Highly qualified specialists spend much of their time sorting, cross-checking, reformatting and re-keying text rather than making regulatory judgements.
Error-prone
A wrong strength in section 2, an excipient missing from 6.1, or a document filed in the wrong module leads to validation queries, requests for information and delays to market.
Hard to scale
Since the UK left the EU, many products need parallel UK and EU documentation, and international filings add translation. SMEs and consultancies feel the capacity squeeze most.
Our approach
Oxford Expert is not a general-purpose chatbot. Each module follows a defined regulatory workflow with published, auditable rules. The AI does the mechanical work, and decisions stay with the regulatory professional.
02 · Product
Four modules covering the submission lifecycle
Each module works on its own and they share one knowledge base, one audit trail and one set of reference data. Teams can start with one process and add the others later.
SmPC/PIL AI editor
Prepares the SmPC or patient leaflet for a generic or hybrid product from the reference product's text, and applies the rules of the target regulator.
You provideReference SmPC (PDF, scan or Word) and a reusable product card
You getA clean Word document and a tracked-changes review copy
- Keeps the reference product's clinical text and replaces all product-specific data: name, strengths, composition, excipients, shelf life, MAH
- UK/MHRA and EU QRD rule sets: 148 documented rules across the SmPC sections, viewable and exportable
- Never invents data: missing values are flagged as [MISSING: …] and listed for the expert
- Regulator-response mode changes only the sections named in an agency letter, each linked to the request
- Automated checks of identity, clinical text, numbers and generic data before the report
Replaces: manual side-by-side editing of reference product information, line by line.
CTD dossier builder
Turns a folder or ZIP of dossier documents into a structured CTD dossier and a submission package, in seven guided steps.
You provideA ZIP archive or individual PDF, Word, XML and Excel files
You getA CTD tree, a gap report and an eCTD
index.xml package- Finds the right CTD section for each document from folder names, file names and content, and reads scanned pages with OCR
- Target structures for UK/MHRA, EU/EMA, US/FDA and WHO, plus other national formats
- When the file name and the content disagree, it shows both sections and the specialist decides
- Compares the structure against what was uploaded and flags facts that differ between documents
- Builds and validates the XML package, with files renamed and arranged as the format requires
Replaces: days of filing, renaming and cross-referencing before publishing.
Dossier completeness assessment
A pre-submission check that answers three questions: is everything there, is each document right, and do the documents agree with each other?
You provideThe dossier, plus a short card: procedure, product type, flags
You getA completeness score and a gap list with evidence for each finding
- Level 1: are the required documents present? Requirements follow the procedure and product type (generic, hybrid, biosimilar, orphan and others)
- Level 2: does each file contain what that document must cover?
- Level 3: are names, strengths, sites and other facts consistent across files?
- Every requirement gets a status (OK, gap, justified absence, not applicable or cannot verify), so the score is never inflated
- A rule set with IDs, sources and expert-check notes, exportable to Excel for QA review
Replaces: manual checklists and validation queries discovered after submission.
Document translation
A regulatory translation pipeline that keeps terminology, numbers and document structure intact, and shows its quality checks.
You provideDOCX, PDF (including scans), eCTD XML, Excel or PowerPoint, plus optional glossaries
You getA rebuilt Word document and a QA report
- Context-aware, two-pass translation (draft, then review) with a regulatory style prompt
- Terminology control: built-in EMA/ICH glossary, your glossaries (CSV, XLSX, TMX, TBX) and translation memory
- Deterministic QA of terminology, consistency and numbers and units, plus an AI check for omissions or additions
- Product names, codes and INNs are protected, and tables are translated cell by cell with their layout checked
- Headings, lists, tables, footnotes, headers and footers are rebuilt in the output document
Replaces: outsourced first drafts, and manual checks of numbers and terms in every table.
03 · How it works
The AI does the drafting. Experts approve every result.
The same pattern applies in every module. Nothing becomes a submission document until a qualified person has reviewed and accepted it.
Upload
Documents, a ZIP dossier or a reference SmPC. Scans are recognised automatically.
UserAnalyse and draft
The module classifies, drafts, checks or translates, following its published rule set.
Oxford ExpertExpert review
Findings, open questions and tracked changes are presented for the specialist to accept or correct.
Regulatory expertExport with evidence
Word, XML and Excel outputs, with an audit trail of who changed and approved what.
Oxford Expert + user04 · Business value
Estimate the capacity you could free up
Change the figures to match your team. The time savings per item are working assumptions for discussion, and a pilot measures the real figures on your own documents.
Estimated annual impact
0specialist hours freed each year
£0value of that time
0full-time equivalents (1,650 hours per FTE)
An illustrative estimate, not a quote or a guarantee. Faster time to submission and fewer validation queries are not counted here.
Validate these figures in a pilot05 · Trust and compliance
Designed for regulated environments
In regulatory work an error is costly, so Oxford Expert is built around evidence, traceability and human control.
Human in the loop
Drafts never become records on their own. Experts accept, edit or reject every change, and open questions are listed explicitly.
Audit trail and quality journal
Actions, versions and approvals are logged. A quality journal records how module results were evaluated against test cases.
Transparent rules
Every module publishes the rules it applies, with IDs and sources, exportable to Excel, Word or JSON for review by your QA team.
Your data stays yours
A dedicated instance per customer, on UK cloud hosting or on your own infrastructure. Processing follows UK GDPR, and customer documents are not used to train shared models.
Model-agnostic
The language model can be swapped. It can be a commercial API or a local, open-weight model, so confidential documents need never leave your network.
Validation-ready
Designed with GxP computerised-system principles (GAMP 5, Annex 11) in mind. Documented requirements and test suites support your own validation.
06 · Working with us
Start small, prove value, then scale
Built for marketing authorisation holders, generic and specialty manufacturers, regulatory consultancies and CROs, from SME to enterprise.
Generic and hybrid MAHsRegulatory consultanciesCROsBiotech SMEsContract manufacturers
Pilot
Fixed scope, 6–8 weeks
- One module on one real product or dossier
- Success criteria agreed up front: time, accuracy and findings
- Side-by-side comparison with your current process
- A written results report for your management
Team subscription
Annual licence, per team
- Any combination of the four modules
- Dedicated UK-hosted instance
- Your glossaries, templates and reference data loaded
- Onboarding, training and support
Private deployment
On-premise or private cloud
- Runs inside your network, with your own models
- Integration with document management and RIM systems
- Validation documentation package
- Custom rule sets and modules
07 · Traction and roadmap
A working platform, ready for UK pilots
The four modules are built and running, and have been tested on real dossiers of more than 300 documents. Our next milestones focus on UK adoption, assurance and scale.
Now
Product built
- Four modules live on one platform
- UK/MHRA, EU/EMA, US/FDA and WHO structures
- Audit trail, quality journal and published rule sets
- Automated test suites for each module
Next 6 months
UK validation
- Paid pilots with UK MAHs and regulatory consultancies
- Independent benchmarking of accuracy and time saved
- UK-hosted production environment and Cyber Essentials Plus
- Expanded MHRA-specific rules for product information
6–18 months
Scale
- ISO 27001 information security certification
- Connectors to document management and RIM systems
- Validation package for GxP customers
- Hiring regulatory and engineering staff in Oxfordshire
Pilot partners
Regulatory teams ready to test a module on a live product.
R&D collaboration
Partners for Innovate UK and other collaborative R&D programmes.
Academic partners
Universities interested in Knowledge Transfer Partnerships on regulatory AI.
Investors
Who see regulatory AI as infrastructure for UK life sciences.
08 · Founder
Scientific rigour behind the product
Anna Koshechkina, PhD
Founder, Oxford Expert Limited · Oxford, United Kingdom
LC-MS/MSProteomics and metabolomicsRegulatory compliance20+ years in analytical science
Anna is an analytical scientist with more than 20 years' experience in food, nutritional and pharmaceutical analysis. She works as a researcher in a proteomics and metabolomics laboratory and is an LC-MS/MS expert.
As compliance lead for food supplements at a nutrition institute, she has worked on regulatory compliance and the detection of undeclared pharmaceutical substances. That work showed her how much product quality and consumer safety depend on reliable, well-documented evidence.
Anna founded Oxford Expert Limited to bring that rigour to regulatory work. Its tools let specialists spend their time on scientific judgement instead of paperwork, and it offers professional education to build the skills to use them.
View LinkedIn profile09 · Questions
Frequently asked questions
Does the AI make regulatory decisions?
No. Oxford Expert drafts, classifies, checks and translates. Every output is presented to a qualified person, who accepts or corrects it, and where data is missing the system says so rather than guessing.
Where is our data stored and processed?
In a dedicated instance for your organisation, on UK cloud hosting or on your own infrastructure. Your documents are not used to train shared models.
Which language models do you use?
The platform is model-agnostic. It works with commercial APIs and with locally hosted open-weight models, chosen to fit your confidentiality requirements and budget.
Which regulators and formats are supported?
ICH CTD Modules 1–5, with target structures for UK/MHRA, EU/EMA, US/FDA and WHO, plus additional national formats. Product information rules cover UK/MHRA and the EU QRD template. Inputs include PDF (including scans), Word, Excel, PowerPoint and eCTD XML.
How long does a pilot take and what do we need to provide?
Typically 6–8 weeks for one module. You provide a representative product or dossier and a reviewer's time; we agree the success criteria with you and report the results in writing.
Can we use it alongside our existing systems?
Yes. Modules take standard files in and produce standard Word, XML and Excel outputs. Enterprise deployments can integrate with document management and RIM systems.
10 · Next step
See Oxford Expert on your own documents
Tell us which process slows your team down most. We'll come back with a short demo and a pilot outline.