HELPING OUR CUSTOMERS TO MEET

QUALITY CONTROL STANDARDS

WHO WE ARE

QUATRE LAB is a Contract Research Organization (CRO) on the path to become an accredited pharmaceutical company under the GMP guidelines set by AEMPS, the competent regulatory authority in Spain.

COMMITMENT TO EXCELLENCE IN ATMP QUALITY CONTROL

Excellence in Validation and Regulatory Compliance

At the core of our mission lies a commitment to excellence at every stage of quality control. With extensive expertise in regulatory affairs, we provide tailored solutions that ensure compliance with the highest standards, facilitating the validation and safe commercialization of advanced therapeutic products.

Our Meticulous Approach

We apply a rigorous and structured methodology that includes:

-Comprehensive Research to design and develop customized quality control strategies tailored to each project’s specific requirements.

-Rigorous Testing and Validation of critical assays to ensure accuracy, reliability, and consistency in results.

-Strict Regulatory Compliance to guarantee quality and safety.

Specialized Expertise in ATMPs

We specialize in the qualification and validation of assays and quality controls for Advanced Therapy Medicinal Products (ATMPs), collaborating with our clients to meet the most demanding regulatory requirements. Key areas of expertise include:

-Potency: Assessing product effectiveness.

-Purity: Ensuring the absence of contaminants.

-Strength: Measuring the concentration of active ingredients.

-Safety: Verifying product integrity and risk absence.

-Cell Banking: Validation and control of cell lines used.

OPTIMIZING R&D WITH USER-CENTERED QUALITY CONTROL SOLUTIONS

User-Centered Innovation for Well-Being and Progress

We prioritize the needs and expectations of our clients, emphasizing human well-being and the advancement of science in a responsible, sustainable way. Through a user-centered approach, we deliver innovative solutions that align with the highest standards of efficacy, safety, and impact.

Tailored Quality Control Services

Our QC services are designed to adapt to the unique needs of each client. We listen closely to their goals, challenges, and expectations, delivering customized, optimized analyses for a diverse range of clients, including:

-Biotech Companies.

-Pharmaceutical Enterprises.

-Public and Private Health-Related Institutions.

Driving Innovation and Supporting R&D

We actively collaborate with our clients in the design and development of innovative projects within the sector. By offering expert advice and support for their R&D plans, we assist with:

-Experimental Studies.

-Qualification Processes.

This approach helps our clients optimize their time, resources, and outcomes, ensuring the success of their research and development efforts.

SCIENTIFIC CONSULTING

In addition to our QC services, we offer specialized consulting to address the most complex challenges in ATMP validation and Regulatory Compliance.

OUR HISTORY

2021

QUATRE LAB´S
INCEPTION

A pioneering biotech
revolution begins

Columbus Venture Partners ideates & founds the company in late 2021 through it´s Life Sciences Fund III. Miramón Technology Park in Spain is chosen as its strategic hub.

2022

LAUNCHING
OUR VISION

Talent recruitment
Gaps & shaping

We finalize the location, initiate the engineering project, establish the Quality Assurance system, and commence talent recruitment while studying current market gaps.

2023

GENESIS &
VALIDATION

Hurling R&D activity
& GMP construction

We secure our first Research & Development (R&D) clients while we simultaneously we advance in the construction of QUATRE LAB’s main goal: our GMP compliant facilities.

2024

ELEVATING
STANDARDS

AEMPS accreditation
& GMP client partnerships

Regulatory Milestone: Inspection by the Spanish Agency for Medicines & Medical Devices will secure our first GMP clients, showcasing our commitment to quality and growth.

2025

DIVERSIFYING
HORIZONS

Scaling QC & Expanding
to New Cities

We will expand our testing capabilities, our team and geographical reach nationwide, demonstrating the ongoing evolution and success of QUATRE LAB.

HOW WE DO IT

By embracing these values, we strengthen the foundation of our organization, ensuring its ability to adapt and thrive in a constantly changing world. These values aren’t just lip service; they’re the driving force behind every choice we make and every direction we take. Together, they light the path ahead, leading us toward a future characterized by achievement, sustainability, and mutual success.

GRANTS

BUSINESS R&D SUPPORT GRANT PROGRAM – HAZITEK

The QUATRE LAB team would like to thank the HAZITEK 2023 business R&D support program, subsidized by Eusko Jaurlaritza – Basque Government and the European Union, for the grant received for Strategic Project No. ZE-2023/00039 – MAPAAV project, in which we are working on a new high-performance multidisciplinary analytical platform for a more biosecure and stable production of adeno-associated vectors for gene therapy

KIT DIGITALA

We are pleased to announce that our company has been awarded the Digital Voucher from the Kit Digital program, an initiative of the Spanish Government aimed at boosting the digitalization of small and medium-sized enterprises. This program, funded by the European «Next Generation EU» funds under the framework of the Recovery, Transformation, and Resilience Plan, aims to improve the level of digitalization of Spanish companies.

GAUZATU INDUSTRIA 2023

We are pleased to announce that QUATRE LAB has been awarded a grant from the Gauzatu Industria program, an initiative by the Basque Government aimed at promoting the transformation and modernization of the industrial sector. This grant will enable us to carry out significant innovation and digitalization projects, optimizing our production processes and improving the sustainability of our operations.

MISION

QUALITY

SAFETY

EFFICACY
OF ATMPS

At QUATRE LAB, our mission is to ensure the quality, safety and efficacy of ATMPs by providing industry-leading testing and certification services. We work in partnership with our clients to drive innovation and promote the advancement of medicine.

Quality Advanced Therapies Research, S.L. holds the Authorizations for Type 2 contained use Facilities (A/ES/23/I-01 and A/ES/23/I-50) to work with genetically modified organisms (Activity Authorizations A/ES/23/01 and A/ES/23/140) granted by the Interministerial Council on Genetically Modified Organisms (CIOMG), affiliated with the Ministry of Agriculture, Fisheries, and Food of Spanish Government.

Paseo Mikeletegi 81 A
20009 Donostia - San Sebastián
Basque Country

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