AstraLabel SOLO — Regulatory Affairs
Upload once. Structured ePI distributed to every relevant repository, in every market, automatically.
AstraLabel SOLO removes the market-by-market distribution burden from your regulatory team. Your team manages the content decisions. PLA manages the distribution infrastructure — 46 countries, 29 languages, format-compliant in every market.
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The distribution problem that regulatory teams own
The ePI challenge your team is actually responsible for — and where it gets hard.
- 01Content quality is your team's responsibility. Distribution infrastructure is not your team's core competency — and it shouldn't have to be. Regulatory teams own the intellectual decisions: what the label says, what the regulatory authority requires in each market, what has been approved. The distribution layer — getting that content into 46+ national repositories in the correct format — is engineering infrastructure, not regulatory affairs.
- 02Every national health authority has its own format requirements — and they change without notice. The EU ePI framework provides a common direction. National implementations vary. Format specifications, metadata standards, and submission protocols differ market by market, and are updated by national authorities on their own timelines. Keeping 46 market integrations current is a standing technical operation.
- 03The submission backlog grows faster than it can be cleared without automation. A major label update affecting 30 markets requires 30 separate submissions, each in the correct format for that market. Done manually — or semi-manually, with a small regulatory operations team — this backlog compounds. AstraLabel makes it a single event.
The operating model
What the split between your team and AstraLabel looks like in practice.
Your regulatory team owns
Content creation — the label text, the regulatory decisions, the market-specific requirements.
Regulatory review and approval — your existing review process, your existing authoring tools, unchanged.
Submission strategy — which markets, which timelines, what to prioritise.
AstraLabel manages
Distribution infrastructure — integrations with 46+ national health authority repositories.
Format compliance — structured content in the correct format for each market, maintained as national requirements evolve.
QR code generation — GS1 Digital Link compliant, accessibility-first rendering, 29 languages.
The result: a label update approved in your system distributes to every relevant market simultaneously. Your regulatory team's capacity goes to regulatory decisions — not distribution logistics.
Technical architecture
Built on the standards that regulators are moving toward.
FHIR-native content model
AstraLabel uses HL7 FHIR as its native content model — the standard direction for structured ePI under the EMA framework. Content authored in FHIR-structured XML is natively compatible with the distribution layer.
Repository integrations — maintained
46+ national health authority repository integrations. Each maintained by PLA as the responsible party for format compliance. When a national authority updates its submission format, PLA updates the integration — not your team.
QR code delivery
GS1 Digital Link QR codes for physical packaging. Accessibility-first structured eLeaflet rendering. 29-language support. The QR code on the pack is static — the content it resolves to is always the current approved version.
The ePI transition timeline
Where the EU ePI transition stands — and what your team needs to have in place.
The EU ePI transition for human health medicines is an ongoing regulatory programme driven by EMA. The direction is clear: structured electronic product information, distributed to national health authority repositories, replacing or supplementing paper-based SmPC and package leaflet delivery.
For regulatory affairs teams, the practical question is: when national health authorities begin requiring structured ePI submission as a standard expectation, is your organisation's distribution infrastructure ready?
AstraLabel SOLO is production-ready today — with 46+ market integrations live and a track record of regulatory submissions across major EU markets.
"The regulatory team's job is to know what needs to go on the label and get it approved. The distribution infrastructure — how it gets into 46 repositories in the right format — should not be an in-house engineering problem."
The in-house build objection
"We are building our own solution."
Regulatory teams at large MAHs often have internal ePI programmes underway. The common architecture: an internal content management and authoring layer — which the internal team builds and operates well — plus a distribution layer, which is where internal builds consistently underperform.
AstraLabel does not compete with your internal CMS. It is the distribution layer you connect to after content is approved. Many of our customers run internal authoring platforms alongside AstraLabel SOLO. The internal system handles content creation and approval. AstraLabel handles the 46-market distribution problem that internal systems cannot solve cost-effectively.
Common questions
Frequently asked questions
We have an internal regulatory information management system (RIMS). How does AstraLabel interact with it?
How does AstraLabel handle market-specific regulatory requirements that differ from the core EU framework?
What happens when a national health authority rejects a submission?
We already have ePI live in a few markets using a different approach. Can we migrate to AstraLabel without disrupting live markets?
Does AstraLabel support the structured SmPC as well as the Package Leaflet?
See the distribution layer demonstrated for your market footprint and product portfolio.
A 30-minute regulatory operations walkthrough. We map the AstraLabel distribution model to your current markets, your current regulatory submission process, and your existing tooling.
Schedule a regulatory demonstration