Dossier compilation

Services

Veraque will be glad to help you on your regulatory dossier compilation projects. Our team has more than 10 years of experience and will treat all your requests with empathy.

We live your needs.

In case you are looking for more details about the regulatory processes in Mexico, please visit our

A dossier or a file, in regulatory terms, is a group of documents that are submitted to the ministry of health in order to receive an authorization. The key point is to understand which documents must be presented. 

In Mexico we have several types of processes for a medical device. Some examples:

  • New Registration.
  • Technical and administrative modification to a registration.
  • Renewals (sanitary registrations must be renewed every 5 years).
  • Import permits.

Every process must be chosen carefully. For instance, a new registration can be submitted through a third party reviewer or directly to COFEPRIS. This saves time. Another example is if your product has been approved in the USA, Canada or Japan, then, you can apply through an easier process. 

This is especially useful when:

You want to make a few trials to better understand the regulatory process.

You do not have sufficient human resources or do not have experience for a particular process.

You need a specialized consulting firm that can help you with your regulatory matters in their entirety relative to Mexico.

At Veraque, we understand that sometimes you just don’t want to handle those decisions on your own and we can help you to evaluate your strategy and support you compiling all the documents to be presented in COFEPRIS. Even if you are working with a distributor, you have your own office representation, or a specialized software to compile the paperwork, we will adapt to your situation to work along with your team.