regulanet®
When a project needs specific regional expertise and knowledge, we leverage regulanet®.
Development, regulatory, and market access requirements around the world are constantly evolving and growing in complexity. At the same time, development programs are becoming increasingly more global; in-depth knowledge of multiple regions is key to success. We meet this need for specialist expertise around the globe by leveraging our exclusive and long-established platform of trusted experts: regulanet®.
We founded regulanet® in 2001. It brings together independent development, regulatory, and market access experts in more than 90 countries worldwide, working to a common set of standards. When it makes sense for your project, a regenold project lead ensures that your project is supported by the right mix of global and regional experts, driving it forward efficiently. Wherever local expertise is needed, it is delivered through that single accountability line.
Sometimes it makes more sense for clients to work directly with one of our regulanet® partners. In those cases, we refer you to the partner best suited to your needs.
The Right Experts, Consistent Standards
We understand that in an ever more complex development, regulatory, or market access environment, having the right expertise and knowledge across different regions plays a critical role in the success of our client's development programs. Our regulanet® partners have hands-on regional knowledge, they have long-standing and impactful relationships with health authorities, and they can provide agile and flexible resource at the time the project requires them. Alongside this, as a result of our longstanding partnership, our regulanet partners are always at the ready to integrate seamlessly into the project team.
regulanet® is structured to make that seamless and timely integration possible. We work to a common set of standards on communication, documentation, project handover, regulatory writing conventions, and how to handle authority interactions. Where a project requires qualified partners, we have already qualified them, or we do so before the work starts.
The partners themselves are experts we have worked with for years, often across many projects. When we bring in an expert to work on a project, we already know how they document, how they engage with authorities, and how they integrate with the rest of the team.
How We Leverage regulanet®
No two projects are the same. Each one involves a different set of countries or regulatory jurisdictions, a different mix of expertise, a different timeline, and often a different starting point.
regulanet® allows us to work with this kind of variety. For some projects, a regenold project lead provides leadership and a single and accountable point of contact for our clients. The project lead is accountable for the contract, the timeline, and for bringing together the right experts to support the project, working in partnership with regulanet® experts as required. If you are looking for support in a specific region or area of expertise, we also offer the flexibility to make a direct connection with the regulanet® partner.
We maintain and manage regulanet®; we have a longstanding partnership, working relationship and most importantly trust with all of our regulanet® partners. We understand which of our partners has the regional expertise and knowledge to solve a specific problem or task, and we can seamlessly include the right experts in your projects. Whether we lead, refer, or run a project together, you get one coordinated solution.
Why We Built regulanet®
regenold was founded in 1994, just as the European Mutual Recognition Procedure and the centralised procedure were starting to operate. From the very beginning, our work involved getting products approved across multiple European markets at once, and we understood early on that this needed a broad team to do well. Each country has its own authority, its own interpretation of international guidelines, and its own way of handling the national steps in international procedures.
By the late 1990s, we were running enough international procedures to know what we needed: experts on the ground in each relevant country, working with their authority every day, in the local language. We started building those relationships, and in 2001 that work became regulanet®.
Twenty-five years later, international and global procedures remain a core part of what we do, and regulanet® provides the regional expertise and global reach we need to execute them well. Today, regulanet® covers North America, the major Asian, Latin American, Middle Eastern, and African markets, and Europe. The model has supported thousands of national filings in time-critical settings, where hands-on local expertise made the difference between a project being successful or not.
What regulanet® Covers
Across more than 90 countries, regulanet® covers the work your project needs at every stage of a product's life.
Development
Regulatory Affairs
Market Access and Reimbursement
AI and digital expertise runs across all three. Regulanet® partners include specialists in AI implementation, validation, vendor qualification, and the practical use of AI systems in regulated work.
We lead, the right experts are brought in for the specific work, and that work is integrated into your overall project.
Get in Touch
Tell us where your product needs to be approved. We will outline how regenold and regulanet® would work together on your project. To browse the network directly, see regulanet.com.
Get in Touch