Nuestra experiencia

Software Solutions

Cloud-based and pre-validated Quality Management Software built for the life sciences as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions for Use (IFU).

Regulatory Affairs

We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle.

Quality Control

Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.

Quality Assurance

We offer the full range of QA services necessary to get your product to market in a safe and compliant way including auditing from certified auditors, setting up a QMS, and all QP activities.

Qualification & Validation

We guarantee that products meet quality demands and comply with regulation through the qualification & validation of your processes, equipment and software.

Go to market

We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.

Clinical

We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.
Industry
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Qualification & Validation

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Validación de equipos
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Integridad de los datos
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Validación de sistemas informáticos
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Calificación de la infraestructura de TI
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios de vigilancia ambiental
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Proceso y limpieza
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In Vitro Diagnostics:
Medical Devices:
Small Molecules:
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Garantía de la calidad

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Especialista en cumplimiento de normativas
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios de auditoría
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios QP
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In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Consultoría de SGC para empresas de DIV
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Medical Devices:
Small Molecules:
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Cumplimiento de los dispositivos
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Medical Devices:
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Digital Health:
Estudios de evaluación del rendimiento
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
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Control de calidad clínico
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Asuntos reglamentarios

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Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Asuntos reglamentarios para farmacia y biotecnología
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Asuntos reglamentarios de los productos sanitarios
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Medical Devices:
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Digital Health:
Cumplimiento de los dispositivos
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In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Estudios de evaluación del rendimiento
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios de representación en el país
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In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Representante legal Ensayos clínicos
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Persona responsable del cumplimiento de la normativa (PRRC)
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In Vitro Diagnostics:
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Clinical

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Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Soluciones CRO
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Redacción médica
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Soluciones de personal clínico
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios de formación clínica
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Cumplimiento de los dispositivos
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Estudios de evaluación del rendimiento
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:

Control de calidad

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Análisis químico
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Biotech:
In Vitro Diagnostics:
Medical Devices:
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Digital Health:
Validación de métodos analíticos
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Biotech:
In Vitro Diagnostics:
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Small Molecules:
Digital Health:
Validación de la limpieza
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In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Análisis microbiológico
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Digital Health:
Servicios de vigilancia ambiental
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Biotech:
In Vitro Diagnostics:
Medical Devices:
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Digital Health:
Estudios de estabilidad
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Biotech:
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Small Molecules:
Digital Health:
Liberación de QP e importación a la UE
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In Vitro Diagnostics:
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Small Molecules:
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Soluciones y servicios de software

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Scilife
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Etiquetado electrónico / eIFU
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
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Ir al mercado

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Marketing y Comunicación
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Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Estrategia, Comercialización, Operaciones
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