Matías Warscher
I am the founder of Warscher Consulting. For over 27 years I have helped medical device manufacturers and biotech companies bring their products to market, with more than 190 regulatory approvals obtained in Argentina, Brazil, the United States and the European Union.
How I work
I learned that the biggest regulatory cost is not the fee the authority charges: it is the time lost in poorly designed processes. That is why I work differently. Instead of treating each country as an isolated procedure, I design a single strategy that advances across several jurisdictions at once, with a reusable base dossier and a sequence planned so that each approval leverages the next.
It is a profile built for the medtech corridor between Argentina and Brazil, where simultaneous regulatory coordination across markets is still rare.
What you can expect
- Senior judgment, no learning curve.You work directly with someone who has been through these processes hundreds of times.
- Evidence-based decisions.Recommendations with technical, traceable grounds, not loose opinions.
- Focus on time-to-market.Every step is weighed by its impact on when you will be able to sell.
- Rigor and traceability.Documentation that withstands an audit, because it was built for that.
Training and scope
To my field experience I add ongoing postgraduate training in biomedical product development, international trade and finance, which lets me look at each project from its commercial feasibility and market strategy as well, not only from compliance.
Working languages: Spanish · English · Portuguese
How I think about a launch
Beyond the regulatory procedure, I developed my own simulation framework that integrates three domains almost always handled separately: the financial feasibility of a project, the quality design of the formulation and the market entry strategy. The idea is simple to state and hard to do: the technical decision should drive the economic one, and regulatory uncertainty should enter the numbers rather than sit as a footnote. It is the same way of thinking I bring to every consulting project.
Read: why medtech business cases tend to be too optimistic →If you have a product, a quality system or a launch to decide on, let’s talk.
The first conversation is about understanding your case and giving you a first read of the regulatory path.