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.

Services Provided:

• Advice and procedures for obtaining, renewing, and updating Health Registries/Health Notifications/Sales Permits to trade products regulated by INVIMA (medications, homeopathic medications, medications for physiotherapy, dietary supplements, medical devices, diagnose reagents, food, alcoholic beverages, cosmetics, household hygiene products, absorbent products for personal use, pesticides for household use, etc.);

• Development of strategies and analysis of information relevant to the protection of new chemical entities’ test data, NQE;

• Anti-Counterfeiting Strategies and Litigation

• Advice and procedures for obtaining sales permits of products regulated by ICA (sales licenses for food products and mineralized salts for animals, veterinary medicines, biological products, and pet litter, among others);

• Registration of companies and commercial establishments to ICA and INVIMA;

• Scientific and legal analysis of requirements made by health authorities, providing high quality consulting aimed at increasing the chances of achieving success in remediation of proceedings and filing of appeals for reconsideration;

• 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;

• Understanding of the agreements and regulations governing relations between the health industry and health professionals locally;

• Assessment before requesting advertising permits for: medicine, medical devices, homeopathic medicine, dietary supplements, medicine for physiotherapy, and energy drin;

• Penalty proceedings.

Gina A. Arias

Regulatory Affairs Manager

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