At Seratec, we specialize in developing and producing cutting-edge active pharmaceutical ingredients (APIs) for the treatment of rare and orphan diseases.
With over 50 years of experience, we are committed to innovation, rigour, and excellence, providing transformative API solutions, products and services for our customers and the patients we aim to serve.
Our deep expertise, proven methods and multidisciplinary approach allow us to design, develop, produce, and register pharmacologically active molecules with leading regulatory agencies.
Seratec specializes in producing low-volume Active Pharmaceutical Ingredients (APIs) with complex manufacturing requirements and stringent regulatory constraints. Our steadfast commitment to quality excellence ensures the efficacy, safety, and consistency of our intricate pharmaceutical compounds, always adhering to the highest manufacturing standards.
Seratec follows the guidelines of current Good Manufacturing Practices (cGMP) to ensure our commitment to quality and excellence in every aspect of our manufacturing processes.
Seratec offers a comprehensive range of custom development services and Drug Master File (DMF)-driven solutions, including exclusive partnerships tailored to meet the specific needs of our customers.
We offer an existing range of APIs that are currently available or in various stages of development. Contact us to learn more about our products and discover how we can meet your needs, enhance your applications and help you find the perfect solutions to drive your projects forward.
From concept to market launch, we collaborate closely to develop customized formulations, optimize processes, and scale up production efficiently, including:
With Seratec, you have a trusted partner dedicated to supporting your API needs throughout the product life cycle. With tailored solutions and expert guidance, partners can rely on our experienced team for formulation optimization, process development, analytical testing, and regulatory affairs, including:
We offer an existing range of APIs that are currently available or in various stages of development. Contact us to learn more about our products and discover how we can meet your needs, enhance your applications and help you find the perfect solutions to drive your projects forward.
Our expert team designs innovative and effective active pharmaceutical ingredients (APIs) tailored to our customers and patient needs. Our solutions are scientifically sound and practical for production, ensuring cutting-edge pharmaceutical products that improve healthcare outcomes.
Seratec specializes in providing custom operational solutions for our pharmaceutical partners. With our expertise and advanced facilities, we collaborate closely to develop, produce, and deliver high-quality products on time and within budget. Our operational services ensure efficiency and reliability throughout the entire production process.
At Seratec, we prioritize managing the entire life cycle of our pharmaceutical products while maintaining comprehensive documentation. From research and development to manufacturing and distribution, we ensure every stage is meticulously documented to meet regulatory requirements and maintain the highest standards of quality.
Certified for research and development (R&D) by the French Ministry of Higher Education and Research, our R&D activities for active pharmaceutical ingredients (APIs) have been meticulously organized as projects since the 1990s.
This approach ensures consistent quality standards and drives continuous improvement. Seratec’s commitment to maintaining pharmaceutical expertise in France underscores our focus on inspections, approvals, and certifications, reinforcing our dedication to excellence.
At Seratec, quality management is ingrained in everything we do. Our approach to success is built on a foundation of rigorous standards and continuous improvement. We employ a comprehensive quality management system that ensures excellence at every stage of our operations:
Our expert knowledge management system helps achieve strategic objectives such as product execution, control maintenance, and continuous improvement through quality risk analysis.
Our proactive approach to quality risk management involves identifying, assessing, and thoroughly controlling potential risks that could impact product quality, patient safety, or regulatory compliance.
Our resources, including staff, equipment, facilities, infrastructure, and support services such as training, IT systems, logistics, and maintenance, are essential to meeting our high standards.
When deviations from procedures occur or documentation falls short, prompt corrective actions are taken to restore balance, identify weaknesses, and optimize processes for continuous improvement.
Planning, implementing, and evaluating changes are vital to maintaining a robust pharmaceutical quality system. We manage these tasks through a structured change control management system, ensuring continuous operational effectiveness.
Regular monitoring, evaluation, and analysis of processes and procedures are crucial for sustaining performance. Seratec relies on quality and performance indicators, associated with specific criteria, to observe changes at defined intervals.