AstraLabel SOLO — ePI for Top-50 MAHs
Upload once.
Distribute to 46+ markets.
Without rebuilding your regulatory infrastructure.
The Product Trust Platform's full-service ePI distribution layer. You manage content creation and approval. We manage the distribution infrastructure across all relevant regulatory repositories globally.
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The real challenge
Most ePI projects stall at the distribution layer — not the content layer.
- 01The content layer is solvable. Large MAHs have the engineering capacity to build it. Structured XML, QR codes, a content management system, GxP validation — these are hard but tractable problems for a large internal team.
- 02The distribution layer is where in-house builds consistently underperform. Each national health authority has its own submission requirements: format specifications, metadata standards, update notification protocols. Some are aligned with EMA guidance. Others have local modifications. Most are updated periodically — without formal notification to industry. Managing this across a multi-market portfolio is a standing regulatory operations function, not a one-time integration project.
- 03A solution that works in two markets is not a global ePI solution. In-house builds typically reach one or two markets and stop. The maintenance overhead of keeping integrations current across 46+ markets, in 29 languages, is the ongoing cost that was never budgeted — and that makes internal builds brittle at scale.
The model that works
Own the intellectual decisions. Outsource the distribution infrastructure.
Many of PLA's customers run a hybrid model: an internal content platform for authoring and approval, and AstraLabel SOLO for structured distribution and repository submission. This is not a compromise. It is the architecture that makes sense.
What you manage
Content creation. Regulatory review and approval. Version control of your product information. All the intellectual and regulatory decisions about your product. Your existing authoring tools and CMS continue to work.
What we manage
The distribution infrastructure. Integrations with 46+ national regulatory repositories. Format compliance per market. Update tracking as national requirements change. GxP-validated platform with full audit trail. XML conversion included as an optional service.
AstraLabel SOLO — specification
Purpose-built for Top-50 global MAHs
Dedicated infrastructure
Your own dedicated AstraLabel environment. No shared processing queue. Full data separation. Implementation ready in 1–2 months.
API access
Full API for integration with your existing content management or regulatory information management systems. FHIR-native data model. Standard REST endpoints.
GxP & SDLC ready
Full validation documentation package. SDLC compliance documentation. GxP-qualified platform maintained by PLA. No validation burden on your IT team.
Pricing
AstraLabel SOLO: CHF 15,000 / month (CHF 180,000 / year). Includes dedicated infrastructure, API access, and implementation. XML conversion available as an optional add-on service. PLA Members (Standard) receive a 10% discount; Patron Members receive 20%.
Addressing the objection directly
"We are building our own solution."
This is a reasonable position. Large MAHs have the engineering capacity to build a content management layer. The question is the distribution layer.
The integrations, format compliance, and ongoing maintenance across 46+ markets with 29 languages — that layer took PLA years to build. It is the piece that makes the difference between an ePI system that works in two markets and one that works in forty-six.
We are not suggesting a replacement for your internal system. We are suggesting a complementary role: you manage content, we manage distribution. Many of our customers run exactly this split today.
Common questions
Frequently asked questions
We have an internal ePI programme already underway. Why would we look at AstraLabel?
What is the Product Trust Platform — is this different from AstraLabel?
How long does implementation take?
What does 'dedicated infrastructure' mean in practice?
We are a PLA member — what discount applies?
See the distribution layer in action for your market footprint.
A 30-minute demonstration of how AstraLabel SOLO handles multi-market ePI distribution. We map it to your current portfolio and market presence specifically.
Schedule a demonstration