Seratec excels across a range of specialized areas, from developing therapeutically active molecules to providing turnkey solutions for active pharmaceutical ingredients (APIs). These APIs can be supplied with or without exclusivity and are registered with regulatory authorities such as local Health Authorities, the European Medicines Agency (EMA), or the U.S. Food and Drug Administration (FDA).
Seratec offers expertise in the design and optimization of chemical processes, including the study of critical parameters, isolation of key intermediates, and scale-up management (from lab to industrial pilot). These services are provided under contract with pharmaceutical companies, with or without exclusivity.
With extensive experience in pharmaceutical chemistry, Seratec is adept at handling exotic reagents and complex, multistep chemical syntheses.
After developing the desired product, it is essential to ensure its purity and demonstrate the absence of toxic substances, following international standards set by the International Conference on Harmonisation (ICH). These guidelines form the basis for Good Manufacturing Practices (GMP) in Europe and current Good Manufacturing Practices (cGMP) in the U.S.
Registering an active substance requires Seratec to validate its chemical manufacturing process, ensuring the process consistently meets the required purity and quality standards. This validation involves producing at least three consecutive batches to demonstrate reproducibility and performing stability testing in compliance with ICH guidelines.
Seratec’s commitment to excellence in pharmaceutical chemistry ensures that its clients receive innovative and reliable solutions, from initial development to regulatory approval. With a deep understanding of complex chemical processes and stringent quality standards, Seratec is a trusted partner in bringing high-quality APIs to the global market, helping pharmaceutical companies deliver safe and effective therapies to patients worldwide.
At Seratec, our manufacturing plant is dedicated to producing APIs with an unwavering commitment to quality and safety.
The Pharmaceutical Quality System (PQS) is a management framework ensuring consistent production of high-quality products.
An active pharmaceutical ingredient (API) is a substance or mixture used in medicine production, acting as the component responsible for therapeutic effects.