The constraint isn't the obstacle. It's the terrain.
Medical and legal validation of every asset, by market and by brand, built into production instead of bolted on at the end.
Why this rarely works
In most projects compliance comes last. The asset is designed, approved internally, and only then sent for review. It comes back with changes that force the artwork to be redone, and the calendar slips by weeks.
The problem isn't that review is slow. It's that review is treated as a downstream formality rather than a design constraint. A claim you cannot support isn't a legal problem — it's a concept problem, and it can be caught before anything is drawn.
What's included
Medical validation of content
Review of claims, terminology and references against the product's approved labeling. Anything that can't be sourced gets flagged before it reaches design.
Regulatory review by market
The same material is rarely approved identically in two markets. It gets adapted to local regulation — ANMAT in Argentina, ISP in Chile, and the equivalent authority wherever the brand operates.
MLR workflow operated, not just supported
Preparing the asset for the client's medical-legal-regulatory review cycle, including loading it into their platform where applicable, and following it through to approval.
Version-level traceability
What changed, who asked for it, against which reference, on what date. That's what lets you answer an audit months later without reconstructing anything from memory.
Why us
We run materials for pharmaceutical companies across several markets at once, under different regulators and calendars that don't line up. That forces validation to be part of the pipeline rather than a separate stage. Ethics isn't a selling point here: it's the condition for the material to ship at all.
The framework changes with the country
Argentina — ANMAT
The health authority is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. The distinction that organises every asset is the product's prescription status: prescription-only products are not promoted to the general public, and can be promoted to healthcare professionals through channels directed at them. That line defines the channel before it defines the message.
Mexico — COFEPRIS
The Comisión Federal para la Protección contra Riesgos Sanitarios oversees advertising of health products, and an asset may require the authority's prior authorisation before it goes live. Where that permit applies it stops being a parallel formality and becomes a calendar dependency: you plan for it at the start of the project, not once the artwork is closed.
Colombia — INVIMA
The Instituto Nacional de Vigilancia de Medicamentos y Alimentos oversees the promotion of medicines and devices. The usual friction point is consistency between what the asset claims and what the product's current local marketing authorisation says, which does not always match the global material.
Chile — ISP
The Instituto de Salud Pública regulates the promotion of pharmaceutical products, and material for prescription products is directed at healthcare professionals. It is the market where the gap between an HCP asset and a patient asset shows most clearly: they are two different materials, not two versions of the same one.
How an asset is reviewed before it ships
Sequence matters more than thoroughness. Review starts with two facts that are not copy: the product's prescription status and the asset's declared audience. What can be claimed follows from those. The copy is read after that, not before.
On the content itself, three separate things get checked and they are worth keeping separate. The claim, which has to be supported by the product's approved information in that market. The reference, which has to exist, be citable, and actually say what the asset says it says. And the mandatory copy, which changes by country and by product, and which is never inherited from another asset.
Then comes the item that is almost never on the list: the channel. A correct asset published somewhere it can receive comments opens a pharmacovigilance obligation, and that gets solved before the channel opens, not when the first comment lands.
And the closing point, the only non-negotiable one: none of these rules is applied from memory. Each is verified against the requirement in force for that product and that market at the time the asset is produced. Health regulation moves, and an asset approved two years ago proves nothing about today's.
The mistakes that cost the most time
Translating instead of adapting
A global asset translated literally carries its original regulatory framework with it: claims that hold up in one market and not in this one, and mandatory copy that doesn't apply. Translation is the easy part; adaptation is the work.
Reusing legal copy from another asset
Mandatory copy depends on the product, the country and the version of the marketing authorisation. Copying it from something approved last year is one of the most common causes of a full review cycle being lost.
Citing a reference that doesn't say that
The problem is rarely that the source doesn't exist. It's that it says something narrower than the claim using it. Review that works reads the source, not the summary of the source.
Leaving compliance until the end
A claim you can't support isn't fixed with a copy edit: it forces the concept to be rebuilt. Catching it with the artwork finished costs you the artwork.
Opening a channel with no adverse-event protocol
The most expensive mistake and the least visible one, because it doesn't show up until it does. The obligation starts with the first comment, not with the first report.
Questions we get
Do you replace the company's medical or legal department?
No, and nobody should. Final approval always belongs to the client. What we do is make sure the asset arrives at that review already prepared — claims sourced, legal copy correct — so the cycle resolves in one pass instead of four.
Do you work on both patient-facing and HCP-facing materials?
Both, and they're treated differently from the start. What you can say to a healthcare professional is not what you can say to a patient, and that difference shapes the concept, not just the copy.
What about pharmacovigilance on channels with comments?
It's a real obligation and it's designed into the channel from the start: any potential adverse event or product complaint is routed into the company's own process within whatever window their procedure requires. It isn't something you solve after opening the account.
How long does a review cycle take?
It depends on the client's own procedure and, in markets where prior authorisation from the authority is required, on that authority's timeline. What can be shortened is the number of rounds: an asset that arrives with claims sourced and legal copy correct resolves in fewer cycles than one that arrives to be told what's wrong with it.
Does an asset approved in one country work across the region?
Not as it stands. It works as a starting point: the concept is kept, then you check which claims hold up in the new market, what mandatory copy changes, and whether the permitted audience is the same. Treating one country's approval as valid in another is the shortcut that stalls the most material.
Does this replace regulatory advice?
No. What's described here is how we work on an asset, not an interpretation of each country's rules. The requirement that applies to a specific product is set by that market's health authority and the company's own regulatory function; our job is to make sure the asset arrives ready for that review.
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