Regulatory & Compliance
International market access.
We develop global regulatory strategies for the pharmaceutical, medtech, and IVD sectors—for the U.S., Asia (APAC), Latin America (LATAM), and the Middle East (GCC). These strategies can be developed in parallel with EU strategies or as standalone strategies.
What regulatory hurdles are hindering global distribution?
Expanding from the EU into international markets is extremely resource-intensive. Poor planning leads to significant delays:
- Regulatory requirements vary widely—what is sufficient in the EU is often not accepted by the FDA (U.S.) or the PMDA (Japan).
- The legal requirement for local representatives is delaying the market launch.
- Technical approval dossiers require extensive adaptation in terms of language and content to meet national standards.
- Complex parallel approvals are straining the capacity of internal regulatory affairs departments.
Do you already have a detailed, budgeted regulatory approval timeline for your top-performing target markets outside of Europe?
Our services for international market access.
We translate global growth targets into realistic regulatory roadmaps for four continents.
Market Entry Strategy & Prioritization
In-depth analysis of regulatory requirements in potential target markets. We prioritize markets based on revenue potential versus regulatory compliance costs and develop a robust roadmap.
FDA Clearances: 510(k), De Novo, and PMA
Complete preparation and submission of 510(k) or De Novo applications for the U.S. market. We attend FDA pre-submission meetings and assist with the management of the U.S. agent.
Approvals in APAC, LATAM, and GCC
Regulatory approval processes for highly complex markets such as Japan (PMDA), China (NMPA), and Brazil (ANVISA). Coordination of local partners and management of country-specific testing and translation requirements.
Post-Brexit (UKCA) & Switzerland (Swissmedic)
Seamless transition to UKCA marking for the UK market, including designation of a UK Responsible Person. Consulting on the new MepV in Switzerland following the termination of the MRA.
Frequently Asked Questions About Global Approvals.
What is the difference between FDA 510(k) and EU MDR CE marking?
FDA 510(k) is generally a process based on "substantial equivalence" to an existing product. The EU MDR always requires a standalone clinical evaluation. The documentation formats can vary significantly.
Does every country need a local regulatory representative?
In most cases, yes. Countries require a legally responsible local partner (e.g., an EU Authorized Representative, a US Agent for foreign establishments, or a UK Responsible Person). We can assist you in selecting one.
How long does a standard FDA 510(k) clearance take?
Once submitted, a 510(k) clearance process typically takes 3 to 9 months, depending on the completeness of the dossier and any inquiries from the regulatory authority. De novo and PMA procedures take significantly longer.
Is the CE marking still valid in the UK?
The acceptance of the CE marking in the UK is ending for most product categories. Going forward, the UKCA marking issued by a UK Approved Body will be mandatory, subject to complex, product-specific transition periods.
Additional expertise in regulatory affairs.
Submit a project inquiry.
Please briefly describe your current challenge. An expert from our team will contact you shortly.