PV Portfolio Watch

Never miss a safety signal on your products

Every month we read EMA, FDA, MHRA and MENA authority updates for you, keep only what touches your portfolio, and tell you what to change and by when.

Request a pilot month See the free digest

Your portfoliorest

Point at an authority to see which product its alert touches

Free digest or Portfolio Watch

The digest tells everyone what changed. Watch tells you what it means for you.

Free

PV Safety Digest

The monthly overview for the whole industry.

EMA PRAC, FDA and MHRA signals and labeling changes
Filtered for MENA relevance
Verbatim product information wording
Excel and PDF downloads
You check which items affect your products
You write the impact assessment

Read this month's digest

Portfolio Watch

Done for your portfolio

Only the signals that touch your products, already assessed.

Screened against your own product list every month
EMA, FDA, MHRA plus SFDA, Egypt EDA and other MENA authorities you choose
Impact assessment for each relevant signal
Draft SmPC and PIL wording, ready for your review
Action plan with owner and due date, for your PSMF and audit trail
A named PV expert you can call

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How it works

Three steps, then it runs by itself

Example alert

What lands in your inbox

One alert per relevant signal, with everything your QPPV needs to decide and act. Nothing to read for the products it does not touch.

Portfolio Watch · monthly alertExample layout

Your product: Product A, film-coated tablets (marketed in Saudi Arabia, UAE and Egypt)
Source: EMA PRAC recommendation on a safety signal for the active substance
Impact: Label update needed SmPC sections 4.4 and 4.8, PIL section 2 and 4
Draft wording: Prepared from the authority's verbatim text, marked up against your current label
Action: Submit variation in each market. Suggested owner: Regulatory. Due: within the authority's deadline
Other markets: Monitor FDA and MHRA have not acted yet; we flag it if they do

Your time back

How many hours does monitoring cost your team?

Move the sliders to match your portfolio. The estimate is yours: change the minutes to what your team really spends.

Products in your portfolio 25

Authorities you monitor 4

Minutes per product, per authority, per month 15

Reading the update, checking the substance, filing the decision.

Your team spends about

25 h

a month on screening alone, or 38 working days a year. Portfolio Watch gives that time back to your QPPV.

Get those hours back

Request a pilot month

Send us your product list. We send you your first month.

A pilot month shows you exactly what Watch catches for your portfolio, before you commit.

ConfidentialYour product list stays under NDA and is used only for your screening.
Europe and MENA in one reportEU, US and UK authorities next to SFDA, Egypt EDA and other MENA regulators.
Expert-reviewedEvery match is checked by a PV expert before it reaches you.