Know what every regulatory change will do to your business.
Pixdly connects regulatory timelines, supply exposure and financial impact into one continuously updated decision model for every post-approval change.
From change request to global consequence. Regulatory. Supply. Inventory. Finance. One model.
One change. Dozens of consequences.
Moving manufacturing from one site to another sets off a filing in every market, each with its own rules and timing. Teams often have to connect the consequences across multiple systems, functions and local market inputs.
- Regulatory teams work across fragmented systems.
- Approval timing is uncertain, market by market.
- Supply teams often receive regulatory timelines late.
- Finance tends to see consequences after decisions are made.
- Markets are reconciled by hand.
- Historical outcomes are hard to reuse for the next forecast.
- Regulatory information keeps changing.
From change to consequence.
Most enterprise systems own one part of this chain: registrations, change control, or supply planning. Pixdly is designed around the cross-functional decision layer that connects the consequences of one change.
Pixdly reads from the systems you already run (RIM, quality, ERP and supply planning) and returns one model of one change: when each market is likely to approve, whether existing stock survives the gap, what each month of delay costs, and which options change the outcome. After implementation, actual outcomes come back and calibrate the next forecast.
One change. One twin. One decision.
Model a change in your browser.
This runs the same forecasting engine as the product, on an illustrative estate of 24 markets for a fictional biologic. Nothing you enter is stored.
Every number can be traced.
Pixdly informs decisions; it does not make regulatory decisions. Forecasts are ranges under stated assumptions.
Every important regulatory fact carries its source, publication and effective dates, and when it was last verified.
Every forecast lists its contributors: base review time, history, GMP steps, translation, dependencies.
Facts, historical observations, model assumptions and AI hypotheses are never mixed.
Earliest, expected and latest dates. "Insufficient evidence" instead of invented values.
Actual approvals come back and are compared with what was forecast.
Detected regulatory updates and AI readings are marked for review; people decide.
Every edit, assessment and decision is logged with who and when; forecast versions are kept.
Each company's data is visible only to its own members, enforced in the database.
Admin, edit and view access per user, with functional roles for each team.
No guaranteed dates, no regulatory advice, no benchmark claims without data.
Pixdly is not validated software and holds no compliance certification today. Validation support is on the roadmap.
Works with the systems you already have.
Pixdly reads from systems of record and never replaces them. Start with a file; connect systems when you are ready. Read-only by default.
RIM reports, ERP gateways, planning APIs, integration platforms
Available
Your system or integration platform pushes changes as they happen
Available
Excel, CSV, JSON, XML exports with automatic column mapping
Available
Signed webhooks to your systems; Slack
Available Teams: roadmap
Veeva, ArisGlobal, IQVIA, SAP, Oracle, Kinaxis
Roadmap Reachable today via API or files
The expensive part of a change is rarely the filing.
It is everything around it that nobody models together. The examples below are typical patterns, not Pixdly measurements.
Supply learns the regulatory timeline after stock decisions are made. Bridge stock is built too late, or too much.
Old-version stock expires in markets that approved early; write-offs follow.
A slow market runs out of the old version before the new one is approved.
Emergency transfers and air freight cover gaps that were visible months earlier.
Market timelines are rebuilt by hand in spreadsheets for every review meeting.
Regulatory, supply and finance each model the same change separately, with different assumptions.
Pixdly connects your systems. It does not replace them.
- A decision layer over regulatory, supply and finance data
- A model of what one change does across markets, stock and money
- A shared record of forecasts, decisions, reasons and outcomes
- Your RIM system (registrations and submissions stay there)
- Your ERP or supply planning system (stock and plans stay there)
- Your QMS (change control stays there)
- A source of regulatory advice: people decide; Pixdly informs
It gets more useful with every piece you add.
A date, a letter or an outcome is enough to start. Pixdly recognises what it belongs to and connects it, so one approval date becomes part of a product's history, a market's timeline and the next forecast.
- Your products, markets, sites and past approvals, as you already hold them
- Each change with its submissions, questions, approvals and implementation
- Forecasts next to the actual outcomes, so the difference is measured
- Decisions with the reason they were taken and what happened afterwards
- Every item shows its source, who verified it and how confident Pixdly is, and why
- When two sources disagree, both are kept until a person decides
- Similar past cases are shown as historical observations, never as a prediction
- Your private data stays in your workspace and is not used for another company
The history available for your changes depends on what you connect and on the public records Pixdly has reviewed. No figure is shown until enough cases exist to support it.
Estimate it with your own numbers.
Every output is an estimate from your inputs and the reduction you assume. In a pilot, Pixdly records a baseline and measures the real change.
How: effort = changes × hours; reduction = effort × your assumed %, valued at your rate; exposure reduction = exposure × your assumed %. Pixdly cost is yours to enter. Estimates, not promises.
Start with one change. Expand when it proves itself.
An illustrative path; real timing depends on your data and how quickly people can join working sessions.
Maturity, measured from your workspace
What happens to your data.
Stated as it is today. Pixdly holds no security or compliance certification yet; we will not claim one before it exists.
Every record belongs to one company. Database row-level security and server checks keep companies apart.
Viewers read; members work; admins configure connections, credentials and automation.
Edits, syncs, decisions, approvals and writebacks are recorded with who and when.
Each imported value keeps its source, original value, transformation and retrieval time.
Regulated values are never changed automatically. Nothing is written to your systems without an admin's approval.
AI features are off until an admin enables them. They work only on the requesting company's data. Pixdly does not use customer data to train AI models.
Read-only by default, encrypted credentials, signed webhooks, HTTPS only.
Off by default. When switched on, only pooled figures from at least 5 companies and 10 outcomes are shown.
Export your workspace any time. Deletion is handled on request; automated retention settings are on the roadmap.
FAQ
Does Pixdly replace Veeva, SAP or our supply planning system?
No. Those remain your systems of record. Pixdly reads from them and models what a change does across regulatory timing, stock and money.
Where does the data come from?
Pixdly's market library (sourced, with verification dates) plus your data: files, APIs, webhooks. Every value shows its source.
Can we use Pixdly without integrations?
Yes. Upload Excel or CSV exports, or start from the library alone. Connections are optional and can come later.
Can Pixdly integrate with our systems?
Today through any REST API, signed webhooks and files. Named connectors (Veeva, SAP, Kinaxis and others) are on the roadmap and will be built with customers who need them.
Can we start with one change?
Yes, and we recommend it. One real change shows whether the model answers questions you cannot answer today.
How long does implementation take?
A first Change Twin from files can be built in a working session. Connecting systems depends on your IT process. We do not promise fixed timelines before seeing your data.
Who uses Pixdly?
Regulatory operations and CMC regulatory, supply chain, finance, quality, manufacturing, program management and leadership. Each sees the same model from its own angle.
How is customer data isolated?
Every record carries its company. Database policies and server checks are enforced on every query; automated tests check that one company cannot read another's data.
Does our data train AI?
Pixdly does not use your data to train AI models. AI features are optional, off by default, and process only the requesting company's data for that request.
Can we use SSO?
Not yet. Sign-in is by email with invitations. SAML/OIDC single sign-on is on the roadmap.
Can we export our data?
Yes: CSV and JSON exports of changes, scenarios, dates for ERP, and the full workspace.
Can Pixdly write back to our systems?
Only if you enable it per connection, and every write needs an admin's approval. Read-only is the default.
Can we control automation?
Yes. You choose the rules, thresholds and which teams are notified. New connections start in a sandbox until an admin activates them.
What happens if two sources disagree?
Pixdly shows the conflict and keeps the existing value until someone decides, unless you have ranked one source above the other. Regulated values always go to a person.
What happens if an integration fails?
Previously imported data is kept, the failure is shown with its reason, the sync resumes from where it stopped, and your admins are told.
How is forecast uncertainty shown?
As earliest, expected and latest dates from thousands of simulated timelines, with the evidence quality of each market. Pixdly says "insufficient evidence" instead of inventing a value.
How is ROI measured?
At the start of a pilot you record how changes are handled today (hours, people, spreadsheets, meetings). The same is measured afterwards. Only measured differences are called savings.
Model a real change with us.
Bring one post-approval change: a site transfer, a new supplier, a CDMO switch. We build its twin with you in a working session: approval ranges by market, the supply bridge, the cost of delay and the scenarios you would actually consider. Then we ask the only question that matters: what would you use today to answer this?
Prefer to talk first? Talk to a regulatory operations expert.