The questions everyone says can't be answered. Answered.
Pixdly forecasts when every market will approve a manufacturing change, what the change will really cost, and where supply will break. It gets more accurate with every approval your team records.
Uses Pixdly's live market library and simulation. Library values are estimates until calibrated with your own approvals.
A problem that hides in plain sight, because nobody owns it end to end.
Sources: Harris et al., "An Evaluation of Postapproval CMC Change Timelines", ISPE Pharmaceutical Engineering, 2023; Vinther et al., Therapeutic Innovation & Regulatory Science, 2024; Pharmaceutical Commerce, 2026.
Eight questions. Everyone says no. Here is how we say yes.
Every change programme runs into the same wall. Each pair below is a question teams are told cannot be answered, and the harder question that comes right after it. Each answer is a working part of Pixdly today.
When will the last country approve?
"Impossible." No regulator commits to a date, and approvals land years apart.
Pixdly: it doesn't pretend to know one date. It simulates 1,500 possible rollouts across every market and gives you the date you can plan on with 90% confidence, plus the market most likely to be last.
In the product: rollout forecast and timelineAnd if one country is three months late?
"Re-plan in a few weeks." Someone rebuilds the spreadsheet.
Pixdly: drag a slider. The global finish date, supply gaps and extra cost recalculate in under a second, so you see the slack before it is gone.
In the product: stress testIs this change even worth making?
"We find out at the end." Fees, dual production and write-offs are scattered across teams.
Pixdly: totals every cost of execution against the expected saving and gives a verdict and payback period before anything is filed.
In the product: cost and valueHow much old stock do we need, and will it expire first?
"Build a big buffer and hope."
Pixdly: calculates old-version cover for each market against its shelf-life ceiling, flags where stockpiling simply cannot bridge, and prices the sales at risk.
In the product: supply bridge, waves and release matrixCan a 50-market plan be drafted without surveying 50 affiliates?
"Not without months of emails."
Pixdly: describe the change in one sentence. It identifies the product, change type and markets, then builds the plan with each country's route, documents and extra steps.
In the product: plan from one sentenceWhat will the regulator ask, before they ask?
"You can't know until the letter arrives."
Pixdly: predicts the likely questions in each market from the type of change, the market's rigour and the questions your own past plans received, so answers are ready before the clock stops.
In the product: predicted authority questionsCan the forecast get smarter without more work?
"Someone has to keep the tracker updated."
Pixdly: every real approval recalibrates that market. Import years of history in one file, read authority letters with AI, connect your systems, and a daily monitor flags regulator pages that change.
In the product: data hub and review queueCan companies learn from each other without sharing secrets?
"Competitors never share data."
Pixdly: an opt-in benchmark pools only anonymous durations: market, category, days and year. A figure appears only when at least three records from at least two companies exist.
In the product: global benchmarkFrom a sentence to a plan you can defend.
Describe the change
One sentence, or pick from site transfers, CDMO switches, process, method, packaging, labelling and holder changes.
Get the answers
Each market's route and documents, the finish date with its confidence, the cost, the supply bridge, the questions to expect and what to do first.
Let it learn
Record real submissions and approvals, or let your systems send them. Every outcome makes the next forecast sharper.
One change. Every seat at the table.
Regulatory CMC
Routes and documents per market, reliance options, ICH Q12 protocols and the classifications behind every date.
Supply chain
Approval waves, old-stock cover against shelf life, a month-by-month release matrix you can export to your ERP.
Quality
A release gate that stays closed until approval, validation and training are complete, and a check that the change actually works afterwards.
Operations and finance
The full cost of a change and whether it pays back, before the programme starts.
Country affiliates
A computed plan to check, instead of a survey to fill in from scratch.
Works alongside your systems. Doesn't replace them.
Your regulatory and quality systems record what happened. Pixdly tells you what will happen, and what to do about it.
Connect by CSV export or a secure endpoint for integration tools such as Power Automate.
Deepest where others are thinnest
51 markets, with particular depth in regions global tools treat as an afterthought.
Every market rule records the regulation it comes from and who reviewed it.
AI proposals wait in a review queue. Nothing changes your rules until a named person accepts it.
Each company's workspace is isolated at the database level, hosted in the EU.
Forecasts show ranges and say how much real data stands behind them.
Every edit, import and decision is logged.
Bring us the change your team says can't be planned.
Tell us about a site transfer, CDMO switch or portfolio change you are facing. We will come back with a computed plan for it: markets, finish date, cost and supply risk.
Pilots run for three months on one live change programme.
Work in regulatory affairs?
Tell us how long variations really take in the markets you know. Two minutes, anonymous, and you receive the regional benchmark report in return.
Questions people actually ask.
Does Pixdly replace our regulatory or quality system?
No. Those systems record submissions, approvals and change controls. Pixdly reads from them and adds what they don't do: forecasts with confidence, cost, supply impact and recommended actions.
How accurate are the forecasts?
Every forecast is a range, not a promise, and it shows how much real data stands behind it. Accuracy improves as your own approval history and outcomes are added. Starting values come from public guidance and are marked until verified.
Where is our data, and who can see it?
Each company has its own isolated workspace, hosted in the EU. Nothing is shared unless you switch on the anonymous benchmark, which shares only durations by market and category.
What does a pilot look like?
Three months on one live change programme. We load your markets and history, compute the plan, and compare the forecast with what actually happens.
Do you cover our markets?
51 markets today, from major authorities to the Caucasus, Central Asia and the Gulf. New markets can be added with the built-in regulation reader.