A company dedicated to the regulatory support of the health sector.

We provide

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ADVISORY

Regulatory support

At REGULATE we understand the regulatory process established by current national regulations and we explain it to you in simple terms.

If you do not require us to carry out the regulatory process, we will tell you how to do it and you carry out the activities.

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TRAINING

Regulatory issues COFEPRIS

  • All of our training agents have knowledge backed by experience.

  • We have worked within COFEPRIS, authorized third parties or the industry, so we can share our knowledge with you so that you can solve real problems.

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PROCEDURE MANAGEMENT

Before COFEPRIS

  • You do not have the patience or the time to carry out the procedures before the authority? 

    1. We present your procedures.

    2. We follow your resolutions on the COFEPRIS portal.
    3. We collect the available resolutions
    4. We give you the corresponding document

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PROJECT FEASIBILITY

Health supplies and products

  • Do you want to avoid investing in a project with a low probability of regulatory success?

  • We show you evidence of why or why not.

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DOSSIER VALIDATION

Medicines and Medical Devices

  • Do you already have your file ready but are you wondering if it contains all the necessary elements to enter COFEPRIS?

  • Or even worse, do you not know if each document presented in the dossier will be enough to fulfill what is requested in the Check list?

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LABEL DESIGN

Inputs and outputs

  • You already have the regulatory path resolved but do you need to polish your label?

  • Do you want us to shape your idea?

  • We put our creativity to have an attractive image + health compliance on labeling.

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LABEL EVALUATION

Supplies for health

  • Do you want to validate that the content of your labels and back labels is within the provisions of the applicable Mexican regulations?

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ASSEMBLY OF DOSSIER

Medicines, herbal remedies and medical devices

  • You have no idea where to start with the assembly of the dossier?

  • Do not worry, we will contact your suppliers if necessary in order to gather everything necessary for you to obtain the necessary sanitary authorization so that you can market your product in Mexico. 

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HOLDING COMPANY

Inputs and outputs

  • You still don't have a presence in Mexico and want to venture into our country?

  • Don't worry, we can appear as your Legal representative.