Regulatory affairs and ongoing compliance to keep your product on the market
Getting approval is the beginning, not the end. We make sure your product stays current and compliant: renewals, changes, post-market surveillance and the relationship with the authorities.
Registration does not end with approval
Registrations expire, standards change and products evolve. A supplier change, a process modification or a new regulation (the FDA QMSR is the most recent example) can put your compliance at risk if not managed in time. This service exists so that none of it catches you by surprise.
What it includes
- Maintenance and renewal of registrations before they expire.
- Regulatory change management (change control) for product, process or documentation.
- Post-market surveillance and vigilance: event reporting and follow-up.
- Updates to the system and files in response to regulatory changes.
- Support and representation in audits and inspections.
- Technical liaison with ANMAT, ANVISA, FDA and the Notified Body.
Your external regulatory department
For many companies it makes no sense to maintain a full in-house regulatory team. We can act as your external regulatory affairs department: with senior judgment, available when a query, a change or an inspection comes up, and watching what is coming before it becomes urgent.
Frequently asked questions
What happens if my registration expires?
Depending on the jurisdiction, you may lose the authorization to sell and have to restart part of the process. The whole point of this service is to anticipate expiry so that it does not happen.
Do I have to report adverse events?
Yes. Post-market surveillance and event reporting are obligations of the registration holder. We define the procedures and support you in complying with them.
How does the new FDA QMSR affect me?
If you sell or want to sell in the US, your quality system must be aligned with the QMSR, in force since February 2026. We assess your situation and plan the transition.
Can you be our permanent regulatory support?
Yes. We work in long-term relationships, acting as the company’s external regulatory affairs department.
You may also need
Medical device registration and approval
Strategy and management of your device registration with ANMAT, ANVISA, FDA and CE, coordinated in a single base dossier.
View service ComplyISO 13485 Quality Management System
Implementation of your audit-ready QMS, aligned with the FDA QMSR now in force.
View serviceHow do you keep your product current and compliant?
Let’s talk about your registrations, your pending changes and what is coming in your markets.