Quality is at the heart of everything we do.And doing so has given Saneca Pharma an outstanding quality compliance record.
Our drug development quality control services are based on European Good Manufacturing Practice (GMP) principles.
Saneca Pharma also follows guidance from other national and international regulatory boards, such as:
- Japan’s Pharmaceutical and Medical Device Agency (PMDA)
- Korean Ministry of Food and Drug Safety (MFDS)
- US Food and Drug Administration (FDA)
- World Health Organisation (WHO).
- Federal State Institution ‘State Institute of Drugs and Good Practice’ of Russia (FSI SID & GP)
Our quality systems have been developed by our specialist quality unit and all our departments are actively involved in maintaining the highest quality standards to meet your needs. As part of our drug development quality control services, we have four qualified persons (QP) responsible for releasing products to markets, ensuring this step in the process is quick and efficient.
Our manufacturing authorisations and GMP certificates cover:
- Production, testing and release of finished pharmaceuticals
- Production, testing and release of investigational medicinal products
- Import from non-EU areas
- Production and testing of APIs
- Certificate of good distribution practice (GDP)
- Authorisation for handling of opiates and precursors
Our quality team can also advise you on product transfer and development strategy, as well as providing support when compiling quality and technical agreements.
To find out more about our drug development quality control services, contact us.
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