Nuestra experiencia

Qualification & Validation

Qualification & Validation

Quality Assurance

Garantía de la calidad

Regulatory

Asuntos reglamentarios

Clinical

Clinical

Control de calidad

Control de calidad

Software solutions

Soluciones y servicios de software

Go to market

Go to market

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).
Learn more

Regulatory Affairs

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

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.
Learn more

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.
Learn more

Qualification & Validation

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

Go to market

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

Clinical

We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.
Learn more
Industry
All...

Qualification & Validation

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

Garantía de la calidad

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Especialista en cumplimiento de normativas
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios de auditoría
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios QP
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Consultoría de SGC para empresas de DIV
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Cumplimiento de los dispositivos
ATMP:
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 clínico
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:

Asuntos reglamentarios

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

Clinical

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Soluciones CRO
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Redacción médica
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Soluciones de personal clínico
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios de formación clínica
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Cumplimiento de los dispositivos
ATMP:
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
iATMP QP batch release
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Análisis químico
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Validación de métodos analíticos
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Validación de la limpieza
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Análisis microbiológico
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Servicios de vigilancia ambiental
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Estudios de estabilidad
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Liberación de QP e importación a la UE
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:

Soluciones y servicios de software

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

Ir al mercado

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