Description
Our practice is designed to meet all the needs of companies in the healthcare and pharmaceutical sector, providing legal, regulatory, litigation and technical advice, with a vision that monitors the industry, regulatory changes, legal, technological, scientific, and cultural trends that affect the sector, to design products and solutions that anticipate the needs of companies.
Our practice offers a multidisciplinary team, with varied technical approaches that allow us to provide precise concepts and the best advice for companies in the health and pharmaceutical sector, to mitigate the risks of their businesses, and to guide them in the operation of these in accordance with Colombian regulation.
SERVICES PORTFOLIO
Legal Advice in HealthCare Services
- Management of administrative and/or judicial requests and requirements, related to healthcare, complaints, vaccinations, clinical trials, medicinal products, and medical devices.
- Legal advice on the prevention of litigation, judicial and administrative claims.
- Legal advice on dispute management through alternative conflict resolution mechanisms.
- Strategic representation in civil, administrative, constitutional, disciplinary, and ethical proceedings related to health law, medical malpractice and medical liability.
Covid 19 related services
- Response to administrative and/or judicial requests and summons, related to health care, vaccination and clinical trials related to COVID 19 issues.
- Legal advice on vaccine regulatory issues and informed consent related to COVID 19.
- Advice on regulatory issues on clinical trials related to COVID 19.
- Strategic representation in civil, administrative, constitutional, disciplinary, and ethical proceedings related to health care, vaccination and clinical trials on COVID 19 issues.
Clinical Trials
- Advice on legal and regulatory issues in clinical trials.
- Advice on legal and regulatory issues related to ethics committees, informed consent, duties and obligations of clinical trial sponsors and patients' rights.
- Memorandums, legal and regulatory advice for companies interested in conducting and investing in clinical trials in Colombian territory.
- Legal prevention of conflicts related to users or participants in a clinical trial.
- Strategic representation in civil, administrative, constitutional, disciplinary, and ethical proceedings related to clinical trials.
Smarth-Health,E-Health, Mobile-Health
- Legal and regulatory advice to healthcare technology companies.
- Legal and regulatory advice to non-traditional healthcare players.
- Issuance of regulatory memorandums.
- Legal prevention of conflicts related to users and consumers.
- Strategic representation in civil, administrative, constitutional, disciplinary, and ethical proceedings.
- Administrative, judicial and/or extrajudicial defense and representation.
- Representation and response of constitutional actions (acción de tutela) and collective actions (acción popular) etc.
- Legal accompaniment and concepts in the creation of digital health care centers.
Telehealth
- Advice on legal and regulatory issues in Telehealth.
- Legal advice to companies that desire to structure telehealth-related businesses in Colombia.
- Regulatory analysis and elaboration of concepts/memorandums on specific topics such as medical records, informed consent, authorizations, digital and electronic signature, privacy management and confidential information.
- Representation and response of constitutional actions (acción de tutela) and collective actions (acción popular) etc.
- Strategic representation in civil, administrative, constitutional, disciplinary, and ethical proceedings related to telehealth.
Health Infrastructure and Projects
- Legal and regulatory advice for the incorporation of companies in the health sector.
- Consultancy for the structuring and participation in PUBLIC-PRIVATE PARTNERSHIPS projects.
- Advice to private bidders in contracting processes carried out by state entities in the health sector.
- Structuring of health infrastructure projects.
- Legal advice on authorization of health services.
- Legal advice on projects related to Vaccination against Covid-19 by private companies.
Training
- Legal risk management for pre- and court claims.
- Structuring health projects.
- Medicine and technology
- Vaccination Plan.
Cannabis Medicinal
La creciente industria del cannabis medicinal presenta grandes oportunidades y retos para quienes deseen ingresar en este mercado.
Hemos establecido una práctica específicamente direccionada a atender, de manera integral, a los clientes interesados en desarrollar este tipo de negocio.
A continuación conozca nuestras capacidades de asesoría legal en la ruta del cannabis.
Fase 1: Establecimiento de la compañía y la operación
- Constitución de la sociedad y estructuración de contratos
- Registro de marcas
- Financiación
- Administración y gestión de los riesgos de cumplimiento
- Cambios internacionales
- Planeación tributaria
- Contratación de personal
- Gestión de tierra y bienes inmuebles
- Apoyo a inversionistas
- Levantamiento de Capital
- M&A
- Asesoría en materia ambiental
- Aprovechamiento de régimen de Zona Franca
Fase 2: Solicitud de licencias, permisos y registros
- Licencias y cupos
- Procesos sanitarios y regulatorios
- Registro de patentes
- Variedades vegetales
- Habilitación de servicios de salud
Fase 3: Operación
- Apoyo permanente al cumplimiento regulatorio
- Asesoría legal general
- ASG
- Compliance preventivo
- Due Diligence
Fase 4: Comercialización
- Publicidad
- Etiquetado
- Comercio internacional – regulatorio
- Comercio internacional – aduanas
Fase 5: Resolución de conflictos
- Litigios
OUR TEAM
NEWS OF INTEREST