Regulatory
Affairs

OlarteMoure has the ability, knowledge, and experience to efficiently carry out a variety of activities, which go from obtaining sales permits from INVIMA (Health Authority for products for humans) and ICA (Health Authority for livestock products) to building highly complex regional regulatory strategies that meet specific client needs and requirements of the life sciences industry.

Regulatory
Affairs

OlarteMoure has the ability, knowledge, and experience to efficiently carry out a variety of activities, which go from obtaining sales permits from INVIMA (Health Authority for products for humans) and ICA (Health Authority for livestock products) to building highly complex regional regulatory strategies that meet specific client needs and requirements of the life sciences industry.

  • We provide advice on the evolving landscape of the healthcare system in Colombia (Market Access Tendencies, Health Technology Assessment, Price Control Regime for drugs and medical devices in Colombia, Reimbursement schemas).
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  • Company Registration (importers or manufacturers when required)
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  • Submissions before the Specialized Advisory Boards 
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  • Marketing authorizations proceedings for products regulated by INVIMA and ICA (Foodstuff, Cosmetics, Medical Devices and IVDs, Dietary Supplements, FSMPs, Drugs, cannabis based products, and products for agricultural industry
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  • Development of strategies and information analysis for Test Data Protection of New Chemical Entities NEQ.
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  • Pots-registration amendments (technical and legal modifications)
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  • Diagnosis, advice, and support to innovators and entrepreneurs who manufacture medical devices in compliance with requirements and procedures for obtaining sales permits of their products to the FDA in the United States and to the EMA in Europe.
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  • Interviews with INVIMA Officials 
  • We provide advice on the evolving landscape of the healthcare system in Colombia (Market Access Tendencies, Health Technology Assessment, Price Control Regime for drugs and medical devices in Colombia, Reimbursement schemas).
    ———————————
  • Company Registration (importers or manufacturers when required)
    ———————————
  • Submissions before the Specialized Advisory Boards 
    ———————————
  • Marketing authorizations proceedings for products regulated by INVIMA and ICA (Foodstuff, Cosmetics, Medical Devices and IVDs, Dietary Supplements, FSMPs, Drugs, cannabis based products, and products for agricultural industry
    ———————————
  • Development of strategies and information analysis for Test Data Protection of New Chemical Entities NEQ.
    ———————————
  • Diagnosis, advice, and support to innovators and entrepreneurs who manufacture medical devices in compliance with requirements and procedures for obtaining sales permits of their products to the FDA in the United States and to the EMA in Europe;
    ———————————
  • Prepare complex technically supported responses to deficiency letters
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  • Interviews with INVIMA Officials 

ADVICE

DEVELOPMENT OF STRATEGIES

DATA ANALYSIS

A

Procesos Sancionatorios

– Área transversal litigios

– Precios

– Violación a los reglamentos técnicos

-Empresas con cierta reputación

A

Trámites ante el Ministerio de Salud y Protección Social

– Organismos Genéticamente Modificados  (MinSalud + INVIMA)

– Clientes con tecnologías sofisticadas

A

Control de precios de medicamentos

– Multinacionales Farmacéuticas

– Negociadores Mayoristas

– IPS

A

Protección de datos de prueba de nuevas entidades químicas (NEQ)

– Multinacionales

A

Análisis de publicidad de promoción

– Productos regulados por entidades sanitarias