Regulatory
Affairs

Support to foreign companies for the developments of business in Colombia according to the law and norms.

¿How we can assist you?

IconINVIMA license

The analysis and order of the information are essential aspects when submitting the formal application to INVIMA, multiple success stories have allowed us to be successful.

  • Technical and official translations.

  • Analysis.

  • Management, processing and preparing of the technical documents.

  • Review and submitting to INVIMA.

  • Process monitoring.

  • Notification of the administrative acts.

  • Technical and regulatory advice.

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IconCCAA Certifícate

We offer precise solutions in the certification of storage and conditioning following all the quality standards required by law that include staff in charge of examine, preserving and releasing the products after their importation

  • Warehousing for medical devices.

  • Rent services for certified warehouse.

  • Reception and analysis of the product.

  • Advice and/or accompaniment of the audit for the certification to INIVMA.

  • Training Services.

  • Conditioning Services.

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IconQMS (Quality Management System)

We focus in the entire process from the diagnosis, design, implementation and certification of QMS, so that your company can adapt to international markets with the application of ISO 9001:2015 standards for your product or service.

  • Initial diagnosis in accordance with the requirements according to the Colombian norm of NTC ISO 9001:2015.

  • Advices and consultant services about the organization's strategic planning.

  • Mandatory technical documentation processes according to ISO 9011:2015.

  • Internal Audit according to the Colombian norm of NTC ISO 9001:2015.

  • Staff Training Services.

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¡Do not complicate yourself, We will support you!
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