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Regulatory Affairs.

INFINITE is a pioneer company in the management of regulatory affairs in Mexico with a wide experience in Latin America. Therefore we are recognized as a leader by this  professional experience in the preparation of regulatory packages for their submission to the regulatory agencies, including all the import permits that are required for the drug research, medical device or biological sample. Along with infinite you will have all our experience on your side as a great strategic partner giving you all the support necessary for the development of your project.

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Administration of regulatory processes

Regulatory Affairs for the development of clinical research.

INFINITE supports you with your professional expertise to monitor and manage all regulatory processes related to your clinical research protocol, through our team of experts we provide the services from translations, the submission of the documents before the ethics committees and research and submission to COFEPRIS for starting the study.

Since the beginning of infinite we have been characterized as one of our greatest strengths, the adaptation  of clinical research protocols through our expertise in the management of the regulatory framework that we can offer an effective solution, fast, reliable and cost effective-time for the administration of the submission required by regulatory agencies and committees of ethics and research.

To start your clinical research protocols INFINITE offers a comprehensive manner the following modular solutions for the development of his research:

Submission and follow-up of research protocols before COFEPRIS.

Submission of research protocols before committees of ethics and research.

Preparation of information packets for COFEPRIS.

Preparation of information packets for ethics committees and research.

Legal representation for unincorporated enterprises in Mexico.

Import permits for research products.

Simple and certified translations.