Creamos/adaptamos tu dossier técnico a MDR, IVDR "transformando problemas en soluciones". consultoria@a3zadvanced.com
A3Z Advanced is a leading provider of comprehensive services to manufacturers in the pharmaceutical, cosmetics, nutraceutical, and medical device industries. Located in Derio, Bizkaia, Spain, with a primary address at Astondo Bidea, A3Z Advanced specializes in quality control, quality assurance, and regulatory affairs, ensuring that clients meet the highest standards of compliance and excellence.
A3Z Advanced offers a dynamic approach to assessing and enhancing quality systems. The company provides expert consultancy and in-sourced services for medical devices and in-vitro medical devices, covering market access, registrations within and outside Europe, and technical file management for CE marking. A3Z Advanced is also adept at analytical methodology development and validation, creating simple and robust methods for excipients, APIs, and more.
A3Z Advanced is dedicated to transforming challenges into solutions, supporting clients with continuous support that extends beyond method transfer. For additional information, the company’s management welcomes you to visit their offices. A3Z Advanced’s team is committed to ensuring your success. We invite the manager of A3Z Advanced to create a customized and exclusive company showcase and product listing on our platform.
A3Z Advanced es un proveedor líder de servicios integrales para fabricantes en las industrias farmacéutica, cosmética, nutracéutica y de dispositivos médicos. Ubicada en Derio, Bizkaia, España, con domicilio principal en Astondo Bidea, A3Z Advanced se especializa en control de calidad, garantía de calidad y asuntos regulatorios, asegurando que los clientes cumplan con los más altos estándares de cumplimiento y excelencia.
A3Z Advanced ofrece un enfoque dinámico para evaluar y mejorar los sistemas de calidad. La empresa proporciona consultoría experta y servicios subcontratados para dispositivos médicos y dispositivos médicos in vitro, que abarcan el acceso al mercado, los registros dentro y fuera de Europa y la gestión de archivos técnicos para el marcado CE. A3Z Advanced también es experta en el desarrollo y la validación de metodologías analíticas, creando métodos sencillos y sólidos para excipientes, API y más.
A3Z Advanced se dedica a transformar los desafíos en soluciones, apoyando a los clientes con un soporte continuo que se extiende más allá de la transferencia de métodos. Para obtener información adicional, la dirección de la empresa le invita a visitar sus oficinas. El equipo de A3Z Advanced se compromete a garantizar su éxito. Invitamos al gerente de A3Z Advanced a crear una presentación de empresa y un listado de productos personalizados y exclusivos en nuestra plataforma.
Compare A3Z Advanced with 3 companies in Pharmaceutical-Manufacturing
| Comparison Field |
A3Z AdvancedMain Company |
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|---|---|---|---|---|
|
Founded Year
|
— | 2004 | 2020 | 2015 |
|
Company Size
|
— | 51-200 | 11-50 | 2-10 |
|
City
|
Derio, Bizkaia | Petah Tikva, Center District | London, England | Schaffhausen, Schaffhausen |
|
Country
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Spain | United Kingdom | Switzerland | |
|
Skills & Keywords
Comparing with main company
|
32 Total Skills
Pharmaceutical Manufacturing
Quality Control
Regulatory Affairs
Medical Devices
Quality Assurance
CE Marking
Analytical Methodology
Medical devices
Analytical development of proprietary non-proprietary quality control methods
Computer System Validation
Implementación de sistemas de gestión de calidad productos sanitarios
Analytical Instrument Qualification Program
Analytical Quality by Design
Data integrity assurance
HPLC
GAMP 5
UHPLC
ISO 9001
Performance Qualification of GC
GxP
Quality 4.0
ISO 13485
Quality system evaluation
Qualification Lifecycle
Transfer& in situ implementation of quality control procedures
Insourcing
Quality control of pharmaceutical
cosmetics
nutraceuticals
ISO 22716
MDR
IVDR
|
16 Total
1 Common
15 Unique
Match
3%
Common Skills:
Medical Devices
Unique Skills:
CE
Cosmetics
GDPR
GMP
Import Medical Device
ISO 27001
+9
|
19 Total
2 Common
17 Unique
Match
6%
Common Skills:
Medical Devices
Regulatory Affairs
Unique Skills:
Audit
Biotech
Commissioning & Qualification
Computer Systems Validation
EMA
FDA
+11
|
22 Total
2 Common
20 Unique
Match
6%
Common Skills:
Quality Assurance
Regulatory Affairs
Unique Skills:
Audit preparation
Certification
CH-REP
Continuous Improvement
Data Analysis
Gap Analysis
+14
|
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