Quality Policy

1. Introduction

It is the policy of Alpha Bioresearch, S.L. to provide our clients with our experience in the development of clinical research, providing products and services that meet the client's requirements with the highest quality standards and in the committed times, establishing lasting and trusting relationships based on the quality of our services.

To this end, Alpha Bioresearch is committed to meeting the quality expectations and requirements of its customers while complying with all Good Practices (GxP) and current regulatory requirements.

Alpha Bioresearch, applies a Quality Management System (QMS) in accordance with the UNE-EN ISO 9001:2015 standard, the legislation of its sector, the Data Protection Law and the Occupational Risk Prevention Law, ensuring that the pertinent measures are taken to ensure the safety of people.

The maintenance of the QMS is supported by management and covers all levels of the organization. Teamwork is vital to the success of the company and therefore this policy applies to external customers, suppliers and other stakeholders.

All Alpha Bioresearch employees are aware of their roles and responsibilities within their respective departments, with other departments and within the QMS in general.

The purpose of this policy is to describe the elements of Alpha Bioresearch's QMS.

This quality policy is communicated and is available to all employees through Alpha Bioresearch intranet and to any interested party through our web page.

2. Quality in Alpha Bioresearch

Quality is one of the most important success factors for Alpha Bioresearch, in this increasingly competitive environment, in which we develop our work. Therefore, we have set ourselves three main goals related to it:

1. • Continuously improve the quality of our services, and especially, our attention and customer service.
2. • Continuously improve the quality of the processes and results of our daily work.
3. • Continuously improve the direction and management of our Company.

Therefore, this continuous improvement of the QMS at all levels has been established as one of our priority objectives.

Our quality system, following the international standard UNE-EN ISO 9001:2015, focused on processes, aims to establish the Plan-Do-Verify-Act cycle (Fig. 1) for all processes and activities developed in Alpha Bioresearch, S.L.

In addition, Alpha Bioresearch, applies strategies based on the risks management, identifying those factors that could have a negative impact both on the processes and on the QMS itself, established quality controls with the aim of minimizing this impact and maximize the use of opportunities as they arise.

The 7 main elements of our QMS are:

1. • Alpha Bioresearch Values
2. • Management and structure
3. • Documentation process
4. • Management of non-conformities and opportunities of improvement
5. • Quality Assurance
6. • Training
7. • Good Documentation Practices

3. Purpose, Mission and Vision

Purpose
Contributing to the improvement of patients' health

Mission
To drive the development of clinical research with high quality standards by building strong relationships with our clients, generating value for shareholders, sponsors and patients.

Vision
To position ourselves as the company of reference in clinical research services for the small and medium-sized pharmaceutical industry, mainly biotech companies, in Spain and Portugal, with special emphasis on the therapeutic areas of Central Nervous System, Hepatology, Oncology and Cardiology and with the patient at the core of our operations.

4. Alpha Bioresearch vlaues

Professionalism is a constant in everything we do. We care about offering a service of the highest quality, as well as maintaining a proactive and flexible attitude to offer our Clients what they expect at all times.

Alpha Bioresearch Management has identified the following values that represent alpha Bioresearch's culture and are essential to delivering quality to our customers, employees and other stakeholders. These values underpin all aspects of Alpha Bioresearch's QMS and our employees demonstrate this in all aspects of their daily work:

1. • Oriented to Customer Satisfaction
2. • Freedom with responsibility
3. • Commitment and flexibility
4. • Long-term perspective
5. • Innovation and creativity
6. • Dynamism and fun