Regulatory Affairs

The regulatory affairs involves the stages from regulatory frameworks definition, data collection/organization, consultations with the health authority, monitoring procedures, prepare and submit applications and supporting documentation, responding to request, notices, lodging appeals and technical assistance for:

  • Food and alcoholic beverages
  • Cosmetics, hygiene and cleaning products, household pesticides.
  • Medical devices, drugs (medications) and in vitro diagnostic reagents.
  • Phytotherapeutic, homeopathic and biological products and dietary (food) supplements.

INVIMA e ICA

INVIMA (National Institute of Food and Drug Monitoring)

ICA (Colombian institute of agriculture)

  • Establishment before INVIMA
  • Regulatory paperwork
  • Automatic records
  • Sanitary registration with previous study
  • Registration renewals
  • Modifications
  • Certifications and approvals
  • BPM reviews
  • Requirements response
  • Concept for health conditions and associated paperwork
  • Nutrition labeling (resolution 333-2011)
  • Import approval
  • Health notification for cosmetic products
  • Health notification for hygiene and cleaning products
  • Drug evaluation.
  • Certificate for the import of medical devices and in vitro diagnostic reagents

SIC (Superintendence of Industry and commerce of Colombia)

Application for trademark records, brand registration, deposit of trade names, application for patents, industrial designs, trademark renewals, modifications, follow up and surveillance. Integral support to register trademarks with the Superintendence of Industry and commerce of Colombia.

  • Previous consulting
  • Application and Registration
  • Requests submitting
  • Requirements response
  • Notifications follow up