Regulatory affairs: complete, up-to-date files, without chasing documents.
Regulatory affairs make a product marketable and keep it compliant: product file, formula and INCI list, claims, labelling, notifications, country registrations, monitoring. A large part of the work consists of gathering documents from suppliers, the laboratory and marketing, then checking that they say the same thing. Automation takes care of collection and checks; regulatory responsibility remains whole.
The role
Between development, quality, marketing, suppliers and the authorities.
Regulatory affairs say whether a product can be placed on the market, where, and with which statements. They compile and maintain the files (PIF in cosmetics, registration dossiers in pharma), approve formulas, claims and labelling, manage notifications and variations, and follow changes in the texts. In a mid-sized company, a small team often covers every market and every range, with deadlines it does not choose.
Day to day
A typical day.
- MorningReview regulatory news: restricted substances, opinions, guidance, a country’s requirements.
- MorningAsk raw material suppliers for missing or expired documents.
- MiddayCheck a formula, its INCI list and concentrations against the restrictions.
- AfternoonReview a draft label, leaflet or visual and its claims.
- AfternoonComplete a product file or prepare a notification, a registration or a variation.
- End of dayAnswer compliance questions from subsidiaries, export distributors and customers.
The objectives
What the role is measured on.
- Product files complete and up to date
- Market launch dates met
- Notifications and registrations on time
- Valid supplier documents
- Labelling compliant first time
- Responsiveness to regulatory changes
Indicators are named, never quantified: levels depend on each company, and the diagnostic measures them.
Day to day
The problems that come up most.
Supplier documents to chase endlessly
Safety data sheets, specifications, certificates, declarations: documents arrive by e-mail, incomplete or out of date.
Product files assembled by hand
Each file gathers formula, safety data, tests and labelling, copied from several sources.
Claims reviewed as they come
Marketing proposes, regulatory checks the evidence and the wording, often under the pressure of a launch.
Monitoring that is hard to turn into action
A text changes; finding out which formulas and products are affected means going back over everything.
Labels to check line by line
Mandatory statements, ingredient list, batch number, languages: errors are sometimes found after printing.
Different requirements by country
Each export market has its own formats, documents and deadlines, tracked in separate spreadsheets.
By sector
One role, several realities.
- Cosmetics and beauty
Product information file, safety assessment, INCI list, claims and evidence, notification on the European portal, multilingual labelling, export registrations and cosmetovigilance: regulatory affairs accompany each formula from development to the end of marketing.
- Pharma and healthcare
Registration and authorisation dossiers, variations, change control, labelling and leaflets, food supplements and devices under separate regimes: every change to the product or the process has a regulatory consequence to assess and trace.
What changes
Automate the task, keep the judgement.
What gets automated
- Collection of raw material suppliers’ documents, with reminders and validity date checks.
- The INCI list and concentrations calculated from the formula, and compared automatically with restriction lists.
- The product file assembled from the PLM, the laboratory and document management, with the list of missing documents.
- Labels and visuals compared by AI with the file’s data: ingredients, statements, claims, languages.
- Regulatory monitoring classified by AI and matched to the formulas and products concerned.
What stays human
- The decision to place on the market and signing the files.
- Interpreting the texts and approving claims.
- Exchanges with the authorities and safety assessors.
Use cases
How to automate, case by case.
Each case starts from a question leadership teams ask. The starting point, what gets automated, the tools involved, and what stays in the teams’ hands.
How do you automate cosmetic regulatory files (PIF)?
- Today
- For each product, regulatory assembles the product information file from the formula, raw material data, stability and compatibility tests, safety tests, labelling and evidence for claims. Documents come from several departments and suppliers, and the file is rarely up to date when the formula changes.
- What gets automated
- The file is structured once according to the expected sections, and each section is fed automatically from its source tool: PLM, laboratory software, supplier documents, document management. The tool flags missing, expired or inconsistent documents, and a change of formula or raw material reopens the sections concerned.
- What stays human
- The safety assessment, signed by the assessor, and validation of the file remain the responsibility of the responsible person.
- PLM
- Laboratory software
- Document management
- Supplier portal
How do you automate calculating the INCI list from the formula?
- Today
- The ingredient list is built by hand in a spreadsheet: each raw material is broken down according to the supplier’s declaration, concentrations are totalled then sorted. A change of raw material or supplier means redoing everything, and errors end up on the label.
- What gets automated
- Raw material compositions are held in a database fed by supplier documents, read by an AI agent then checked. The tool calculates the INCI list from the formula, applies the ordering and labelling rules, identifies the allergens to declare above the applicable thresholds, and passes the approved list to labelling.
- What stays human
- Reviewing the list and approving it before printing remain regulatory’s job.
- Formulation software
- Raw materials database
- AI document-reading agent
- PLM
How do you automate preparing CPNP notifications?
- Today
- Before each launch on the European market, product information is re-keyed on the notification portal: category, formula, particular substances, labelling, photo of the pack. The work is repeated for each variant, often at the last minute.
- What gets automated
- Notification data is prepared automatically from the product file and the PLM, variant by variant, with a completeness check. The tool keeps the launch calendar and flags products to notify or to update after a change of formula or labelling.
- What stays human
- Entry or submission on the portal and final validation remain done by the responsible person.
- PLM
- Document management
- Deadline tracking tool
How do you automate checking product claims?
- Today
- Marketing proposes texts for the carton, the product page, social media and visuals. Regulatory reviews each medium, checks that the claim is permitted, correctly worded and supported by evidence, and sends comments back by e-mail.
- What gets automated
- A library lists approved claims, with their permitted wordings, evidence and media. An AI agent reads each new text or visual, spots the claims, compares them with the library and flags those that are new, reworded or unsupported. Regulatory only reviews in detail what is flagged.
- What stays human
- Accepting a new claim and judging whether the evidence is sufficient remain regulatory’s decisions.
- Claims library
- AI text-analysis agent
- Online approval tool
How do you automate regulatory monitoring of substances?
- Today
- Regulatory follows official publications, scientific opinions and lists of restricted or banned substances, then searches by hand for the raw materials and formulas affected. The matching takes time and depends on the team’s memory.
- What gets automated
- Monitoring sources are collected automatically, and an AI agent extracts substances, concentrations and application dates. The tool searches for the raw materials containing these substances, then the formulas and products concerned, with their current concentrations. Regulatory receives the list of products to review and their deadlines.
- What stays human
- Interpreting the text and the reformulation or withdrawal plan remain decided by regulatory with development.
- Monitoring tool
- AI document-reading agent
- Raw materials database
- PLM
How do you automate checking labelling and mandatory statements?
- Today
- Each label, carton or leaflet is checked line by line: ingredient list, mandatory statements, precautions for use, period after opening, responsible person’s address, languages. With many variants and packaging redesigns, checking is slow and errors remain possible.
- What gets automated
- The expected statements are generated from the product file and each market’s rules. An AI agent reads the print file or the artwork proof, extracts the texts and compares them with the expected statements, language by language. Differences are flagged with their location on the visual.
- What stays human
- Regulatory approval of the labelling before printing remains signed off by regulatory.
- AI comparison agent
- PLM
- Online approval tool
How do you automate collecting documents from raw material suppliers?
- Today
- For each raw material, regulatory needs the safety data sheet, the specification, the composition, certificates and relevant declarations. They are requested by e-mail, filed by hand, and a document’s expiry is often discovered just when it is needed.
- What gets automated
- The list of expected documents is set by type of raw material. The tool requests them on a supplier portal, sends reminders before expiry, reads the documents received with an AI agent and compares the new version with the old one to flag changes in composition. Formulas using the material are listed automatically.
- What stays human
- Accepting a raw material and analysing a change of composition remain regulatory’s job.
- Supplier portal
- AI document-reading agent
- Raw materials database
- Messaging
How do you automate the regulatory assessment of changes in pharma?
- Today
- Every change of supplier, process, site or specification goes through change control. Regulatory has to assess whether a variation must be filed, and for which dossiers and countries, going back through the registration dossiers by hand.
- What gets automated
- Change requests are linked to the products, registration dossiers and countries concerned. The tool proposes a first classification of the change based on the applicable variation rules and similar past changes, prepares the list of countries and dossier sections affected, and tracks filings until approval.
- What stays human
- Final classification of the change, filing strategy and exchanges with the authorities remain decided by regulatory.
- Change control tool
- Regulatory document management
- Deadline tracking tool
How do you automate preparing export registration dossiers?
- Today
- Each country outside the home market asks for its own documents: certificates of free sale, formulas, studies, translated labelling, legalisations. Requirements are kept in spreadsheets by country and dossiers are prepared one by one, with many documents requested again.
- What gets automated
- A matrix of requirements by country and product family is kept up to date. For each product and each target market, the tool generates the list of documents, gathers those that already exist in the product file, flags those to produce and tracks filing and renewal deadlines with the local distributor.
- What stays human
- The registration strategy by country and approval of the dossiers filed remain regulatory’s.
- Document management
- PLM
- Deadline tracking tool
- Distributor portal
How do you automate sorting cosmetovigilance reports?
- Today
- Reports of adverse effects arrive through customer service, social media, distributors or health professionals, in very varied formats. Regulatory has to identify them, document them, assess their seriousness and spot trends by product.
- What gets automated
- An AI agent reads incoming messages from customer service and other channels, spots those describing an adverse effect and opens a case with the product, the batch and the description. The tool requests missing information, flags potentially serious cases first and tracks the number of cases by product and by type of effect.
- What stays human
- Assessing each case, causality and reporting to the authorities remain regulatory’s job.
- Customer service software
- AI classification agent
- Vigilance tool
- Reporting tool (BI)
Questions from the teams
What teams look to improve.
- Can a regulatory file be automated?
- Its assembly and checks can: data from the formula, raw materials, tests and labelling are taken from their source tools, and the tool flags missing or expired documents. The scientific content, the safety assessment and the signature remain human acts, under the responsibility of the designated person.
- How do I calculate the INCI list automatically?
- From the formula and the composition of each raw material, as declared by the supplier. The tool totals the ingredients, ranks them in descending order of concentration according to the applicable rules, handles low-concentration ingredients and the allergens to declare. The list produced is reviewed before being passed to labelling.
- Can AI check claims?
- It can spot claims in a text, compare them with a library of claims already approved and with the evidence available, and flag risky wording. It does not replace regulatory judgement: it prepares the review and avoids missing a claim slipped into a visual.
- How do I track the validity of supplier documents?
- Each document is recorded with its raw material, its supplier and its validity or revision date. The tool reminds the supplier before expiry, reads new versions received and flags changes in composition. The formulas that use the material are flagged when it changes.
- How do I turn regulatory monitoring into action?
- By linking monitoring to the data: when a substance is restricted or a concentration lowered, the tool looks for the raw materials that contain it and the formulas concerned, with their concentrations. Regulatory receives a list of products to review rather than a text to interpret alone.
- Can the CPNP notification be automated?
- The notification data can be prepared automatically from the product file: category, frame formulation or exact formula, substances to declare, labelling, responsible person. Entry or submission on the portal and final validation remain done by the responsible person.
- How do I manage regulatory requirements across several countries?
- By maintaining a matrix of requirements by country and product family: documents to supply, formats, languages, deadlines, specific statements. The tool derives for each product the list of documents to prepare by market, and tracks files in progress and their deadlines.
- Is dedicated regulatory software needed?
- Not always. When the portfolio is broad and markets are many, specialised software is justified. Otherwise, a custom tool connected to the PLM, the laboratory and document management can hold the files and the checks. In both cases, the quality of raw material data determines reliability.
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