Our Pharma legacy: Over 60 years of experience as an API manufacturer.
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Flawless compliance track record: More than 20 years of operations free from FDA 483 observations and no critical or major findings.
We are the first CDMO that applies eBR connecting to DCS in Spain to ensure compliance and data integrity.
Our commitment to Excellence
Quality is ingrained in our DNA
Our unwavering dedication to compliance with the latest regulations and the highest quality standards builds trust with clients and regulatory agencies alike. With a track record of inspections that speaks for itself (free from FDA 483 observations in over 20 years), we have earned a reputation for reliability, consistency, and quality.
Our Quality System is based on the cGMPs and adheres to the relevant quality guidelines such as ICH & ISPE and allows us to meet high compliance standards while implementing continuous improvement processes.
We keep enhancing our quality system also by digitalization such as eBR (electronic Batch Record) as the first CDMO company applying eBR in Spain. It provides real-time production execution, continuous monitoring and alerts of critical parameters whilst ensuring compliance requirement fulfilment and data integrity.
We adhere to the highest quality standards in every aspect of our processes, ensuring the safety, efficacy and compliance of your Small Molecule APIs and Intermediates. Our commitment ensures Top Pharma Quality.
Inspections & Audits
Our facilities are regularly inspected by Health Authorities (FDA, European Authorities, PMDA, among others) and customers. With a track record of inspections that speaks for itself (free from FDA 483 observations in over 20 years), we have earned a reputation for reliability, consistency, and quality.
Summary of Health Authority inspections
USA, FDA
1999 |
2002 |
2004 |
2009 |
2015 |
2017 |
2023 |
Europe, AEMPS
2012 |
2015 |
2018 |
2024 |
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Japan, PMDA
2007 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2017 |
2023 |
Analytical Services
Our comprehensive analytical departments span the entire product lifecycle, ensuring precision and quality at every stage. Our key capabilities include:
- Development of new analytical methods.
- Optimization of existing analytical methods.
- Verification, validation and transfer of analytical methods.
- Analysis and release of raw materials, intermediates and APIs.
- Support the cleaning validation activities.
- Stability studies to define retest/expiry period of the intermediates and APIs.
- Characterization of standards and impurities.
- Elemental impurities evaluation.
Our laboratories are equipped with the following main instrumentation:
- HPLC
- UPLC
- GC-HS
- HPLC-MS
- GC-MS
- RMN
- DSC
- Analytical Techniques for particle size measurements
- Laser diffraction
- XPRD>Elemental impurities evaluation
CMC Regulatory Services
Our team of regulatory experts play a crucial role throughout the entire project lifecycle, ensuring seamless preparation and delivery of all necessary registration documentation for intermediates and APIs.
They provide comprehensive support, ensuring compliance with the latest regulations and standards, and facilitating a smooth path to market approval for your products.
We handle submissions to global regulatory authorities, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), Japan PMDA, China FDA (CFDA), etc.
Our services include:
- Drug Master Files for the EU, USA, Japan, China as well as other worldwide markets.
- Complete CMC documentation (Module 3.2.S) for approval applications.
- EP-Certificates of Suitability (CEP).
- Notifications of change.
- Assessment reports according to ICH Guidelines (genotoxic and mutagenic assessment, elemental impurities, residual solvents…)
