Tel.: 94 407 40 68

 

Pharma

Asesoramiento jurídico especializado dirigido a empresas del sector farmacéutico, biotecnológico y de productos sanitarios.

 

Los servicios prestados por F&E en relación con este sector requieren una alta especialización, basada en el conocimiento de las peculiaridades que presenta el mismo, siendo principalmente, los siguientes:

Asesoramiento continuado en asuntos mercantiles, societarios, regulatorios y contractuales propios de la actividad ordinaria de las empresas pertenecientes a este sector, tanto en el ámbito nacional como internacional.

Apoyo y asesoramiento en el cumplimiento de la normativa legal y deontológica del sector, incluyendo las obligaciones en materia de transferencias de valor.

Redacción, negociación y revisión de contratos relacionados con la actividad ordinaria de las empresas de este sector:

  • Acuerdos de confidencialidad y acceso a datos por cuenta de terceros con CRO y equipos investigadores.
  • Contratos de distribución, compra de productos, fabricación, suministro o almacenaje, así como de licencia.
  • Contratos vinculados al desarrollo de ensayos clínicos y estudios observacionales, tanto con investigadores, centros de investigación como con CRO y otros terceros prestadores de servicios en el ámbito sanitario.
  • Contratos de prestación de servicios con profesionales sanitarios de conformidad con las previsiones establecidas por el Código de Buenas Prácticas de la Industria Farmacéutica.

Asesoramiento en el cumplimiento de la normativa de protección de datos y de autonomía del paciente en el marco de estudios clínicos.

Asesoramiento en materia de derechos de propiedad intelectual e industrial (PI) y know-how.

Asesoramiento en procedimientos ante la Agencia Española del Medicamento y Farmaindustria.

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