How we work
Three ways to work with us. One team behind all of them.
Start with a single project, keep us as your regulatory team every month, or bring us in for your own clients. The same specialists for Brazil, Europe, the UK and North America.
Three models
Choose how we work together
A single project
A clear scope, a plan and deliverables up to the decision of the authority or Notified Body.
Good for: Launching in a new market · Expanding to another country · Rejected or stalled
- Strategy and classification
- Dossier and submission
- Answers to authorities and Notified Bodies
A monthly regulatory team
We keep your registrations, changes and post-market duties on track, month after month.
Good for: Staying on the market · Audit or inspection coming
- Changes and renewals
- Post-market surveillance
- Quality system and audits
A partner for your clients
For consultancies and distributors who need a regulatory team behind their own clients.
Good for: Consultancies · Distributors
- Deliverables under your brand or ours
- Brazil, Europe, the UK and North America
- One contact person
Project or ongoing support?
Most clients start with one project. Many stay.
Choose a project if
- You have one product and one market in view
- You need a dossier or an answer by a date
- Your team will run the registration after approval
Choose ongoing support if
- You have several products or markets
- Changes and renewals keep coming
- You want one team that already knows your files
In every model
Two specialist teams, one file
Registration and market access, quality systems, risk management (ISO 14971) and audits.
Biocompatibility (ISO 10993), chemical characterization and toxicology, clinical evaluation.
Both teams plan your file together from day one, so the evidence matches what each market asks for.
How it flows
From the first call to market access
Audited and transparent
We regulate ourselves first
- ISO 9001 certified, verified by SGS (Brazil only)
- Led by a former Notified Body auditor
- Controlled internal procedures
- Every step in the Sobel Client Workspace
Can we start with a project and move to monthly support?
Yes. That is how most long-term clients begin.
Do you only work with ANVISA?
No. We work with ANVISA in Brazil, the EU MDR, IVDR and cosmetics rules in Europe, the FDA in the USA, the MHRA and Health Canada.
Who holds my registration in Brazil?
Sobel offers this service through a qualified partner company authorized by ANVISA, which acts as Brazilian Registration Holder. Sobel prepares the registration and coordinates the whole process.
Do your regulatory and product safety teams work on the same project?
Yes. Regulatory & Quality and Clinical Evidence & Product Safety plan your file together from day one, so the evidence matches what each market asks for.
How do I follow my project?
In the Sobel Client Workspace: every step, document and deadline in one secure place.
