In regulatory matters we face a regulatory landscape that changes and evolves.
The Udelá team facilitates the process of registering and maintaining your products in the different markets of LATAM and Mexico.
We know that your most valuable resource is time.
Regulatory Assessment / Gap Analysis
We review and verify that your file is complete and ready to start the technical evaluation process.
Regulatory expert reporting service
Let’s make it easier
We condense the clinical or preclinical information of your product to facilitate communication and analysis to regulatory agencies.
Extensions and modifications
Maintenance of your registration
Once the health registration of a product is obtained, it is subject to modifications.
We help you prepare your dossier, evaluating and verifying that it meets the requirements requested by the regulatory agencies for the maintenance of the health registration.
Save time and optimize the work of your regulatory team.
We take care of the preparation of your dossier. Printing, foliated… What do you need?
We evaluate the technical, scientific, administrative and legal information.
We considerably reduce the risk of having some prevention by the authority, preventing the processes from being extended in time.
Post marketing service
Let’s take the next steps
We value the information of your product so that it can reach the market and advertise itself.
Pharmacovigilance and technovigilance
Every new molecule requires a risk management plan; It is a mandatory requirement to submit to the regulatory authority.
The experts of the Udelá team support you in the elaboration of your plan and in all the corresponding reports that are needed.