Service 02 / 05
Regulatory Coordination.
Clear documentation, labels and claim frameworks — settled before spend scales.
Regulatory requirements for medicinal products, OTC and food supplements differ by category and by market. We map the compliant route per product: classification, artwork and label review, ingredient and claim screening, dossier readiness and coordination with qualified partners and authorities across Europe and selected Latin American markets.
Our approach
Settle the regime, then build the pack.
Almost every expensive regulatory problem we see started as a copy or classification decision made too late. We resolve the regime first, fix the permitted claim vocabulary in writing, and only then let artwork and channel negotiations proceed.
Because AFZ operates a GMP-certified quality system for manufacturing and GDP-compliant distribution, and runs both regulatory regimes across its brands, the assessment comes from operating practice rather than from a checklist.
What you get.
Concrete deliverables — not a strategy deck that dies in a drawer.
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Classification assessment
Medicinal product, supplement or borderline — with the evidence behind the conclusion, per target market.
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Claim framework
The authorised claims you may use, and an explicit list of what is prohibited across all channels.
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Label & artwork review
Mandatory particulars, language requirements and layout checks before print.
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Dossier readiness
Gap analysis against what the authority or notification body will require.
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Authority coordination
Structured correspondence through qualified partners where an authorisation is involved.
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Change control
Assessment of reformulations, new claims or new markets against the existing position.
Built for.
Three situations where this service pays for itself.
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Borderline products
Your formula sits close to a dose threshold and you need a defensible position before investing in artwork.
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Claim-heavy marketing
Your existing copy promises more than the EU Claims Regulation permits and needs rebuilding without losing the proposition.
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Multi-market rollouts
One product, several markets, and no clarity on where the regulatory route diverges.
Common questions.
Straight answers — the rest we cover on a call.
Do you submit dossiers on our behalf?
We prepare and coordinate. Submissions are made by the entity holding the relevant authorisation — us, you or a qualified partner, depending on the market and product.
Can you review copy we already have?
Yes. A claim audit of existing pack and web copy is one of the most common first engagements, and usually the cheapest risk reduction available.
What if a product is reclassified?
Distribution stops until an authorisation exists. We assess exposure across markets and build the remediation path — which is why we push the classification question to the start.
Not sure your claims would survive review?
Send us the pack and the web copy. We will tell you what holds and what does not.
Services are scoped to the product, territory and responsibilities agreed with AFZ and qualified partners. National authorisations, MAH roles and reimbursement pathways apply only where legally applicable and explicitly mandated.