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Your Global CDMO Partner with an International Vision
Unolab Manufacturing
Excellence in Quality and Compliance
At Unolab Manufacturing, quality is the foundation of everything we do. As a global CDMO based in Getafe, Spain, we specialize in the development and manufacturing of sterile single-dose liquid formulations, based on Blow-Fill and Seal technology, primarily in the ophthalmic and respiratory fields. Our commitment to excellence is backed by strict regulatory compliance and internationally recognized quality certifications.
CDMO certified to the
Highest Standards
We manufacture in full compliance with the highest global quality standards, ensuring that every BFS product meets the most rigorous safety and efficacy requirements. Our certifications include:
GMP Certified
Guaranteeing the highest
pharmaceutical manufacturing standards.
ISO 13485
Ensuring excellence in medical device
quality management.
CE Marking
Validating the safety and performance
of our medical devices for the European market.
ANVISA Accreditation
Certifying compliance for
ophthalmic medical device in Brazil.
Manufacturing authorisation for antiseptics for intact skin
Integrated Quality
Management
Our Quality Management System (QMS) is designed to guarantee product integrity at every stage, from development and manufacturing to regulatory approval and market distribution. We continuously monitor and improve our processes through:
State-of-the-Art
Facilities & Technology
Our cutting-edge Blow-Fill-Seal (BFS-Technology) technology allows for safe, sterile, and efficient single-dose liquids production, minimizing contamination risks while maximizing scalability. This advanced technology ensures full compliance with international regulations and delivers uncompromised product quality.
To know more
A Strategic
Partner for
Your Success
years
of experience
Unolab has evolved into a BFS trusted
partner for companies worldwide. Whether you require large-scale manufacturing, new
product development, or regulatory support, we offer
agile, innovative, and flexible
solutions tailored to your needs for sterile unit-dose solutions.
At Unolab, we don't just manufacture products—we help our partners grow. Our
expertise, commitment to quality, and deep regulatory knowledge make us the CDMO of choice for companies
seeking a reliable, high-quality
Blow-Fill and Seal manufacturing partner.
International Expertise
Our team of experts brings a wealth of international experience and knowledge:
- Multilingual staff capable of communicating effectively with clients from various countries.
- In-depth understanding of global pharmaceutical and medical device regulations.
- Experience in managing international technology transfers and product registrations.
Serving a Global Market
Unolab's products and services cater to an international clientele:
- Development and manufacturing of products that meet global quality standards.
- Flexibility to adapt formulations and packaging to suit different market requirements.
- Support for international regulatory submissions and approvals.
Cross-Border Collaborations
We actively engage in international partnerships and collaborations:
- Participation in global industry events and conferences.
- Partnerships with international research institutions and universities
-
Continuous monitoring of global trends and innovations
pharmaceutical and medical device industries.
By emphasizing these aspects, we showcase Unolab Manufacturing as a CDMO with a truly international outlook, capable of serving clients across borders and navigating the complexities of the global pharmaceutical and medical device markets.
Our Values
at Unolab
Manufacturing
At Unolab Manufacturing, our identity is built on five core values that define who we are and how we operate: Excellence, Innovation, Neutrality, Flexibility, and Teamwork. These principles drive our commitment to delivering the highest quality in everything we do and building strong partnerships with our clients.
Excellence
Excellence is at the heart of Unolab CDMO. We uphold the highest manufacturing standards, ensuring precision, safety, and reliability in every sterile unit-dose solution we develop. Our unwavering commitment to quality and regulatory compliance allows us to consistently exceed expectations and provide best-in-class solutions to our partners.
Innovation
We embrace cutting-edge technology and advanced research to stay at the forefront of pharmaceutical development. Our state-of-the-art facilities and specialized teams ensure that every BFS formulation and transfer process benefits from the latest advancements in pharmaceutical science and sterile manufacturing.
Neutrality
As a pure CDMO, we do not commercialize any products, nor do we compete with our clients in the market. Our neutrality guarantees that we are a reliable and independent manufacturing partner, fully dedicated to supporting our client's success without conflicts of interest.
Flexibility
We adapt to the unique needs of each partner, offering a tailor-made approach that ranges from small clinical trial batches to large-scale industrial production. Our capabilities extend across various ampoule sizes, from 0.4 ml to 10 ml with filling ranges starting at 0.3 ml and a wide range of packaging solutions, ensuring maximum customization and scalability.
Teamwork
Collaboration is key to our success. At Unolab CDMO, we work as one integrated team, ensuring seamless coordination between all departments to uphold our commitment to excellence. We also believe in strong partnerships with our clients, fostering close relationships where they feel fully engaged in the manufacturing process, with transparency, trust, and outstanding customer support.
At Unolab manufacturing our values are more than just words
They are the foundation of our culture and the reason we continue to grow alongside our partners. Together, we can turn your pharmaceutical visions into reality, driving innovation and excellence in healthcare worldwide.