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Quality and regulatory affairs

Quality and regulatory affairs

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“Novasep operates a high-performance quality management system compliant with current Good Manufacturing Practices (cGMP). Our teams are dedicated and conduct continuous upgrades to ensure that all Novasep plants meet the highest level of compliance with ever stricter regulatory standards.”
Jean-Claude Romain, Sr VP Quality at Novasep.

All our cGMP production facilities are regularly audited by our customers and all applicable regulatory bodies including the US FDA, local authorities and where applicable, Japan PMDA. All four manufacturing facilities have been successfully inspected by the FDA in 2014-2016 with no 483s. and successfully passed the inspection without any major observations.

Novasep Quality Control

This robust quality system relies on several cornerstones: compliance with regulatory and customer requirements, risk management principles, continuous improvement through the monitoring of key performance indicators (KPIs) and their review by the management. Compliance with regulatory requirements is also assessed during the numerous customer and internal audits carried out each year. Above all, top-quality arises from the daily commitment of all staff involved in manufacturing activities: they know that beyond regulatory compliance, patient safety is what really matters.


Good practices in the manufacture and handling of HPAPIs results from experience and smart consideration of the process as a whole. We combine pragmatic and rigorous approaches to all disciplines including equipment and facility design, process design and development as well as process validation. We ensure that our activities fully guarantee the safety of patients and employees.

Get more details on the management of EH&S aspects for cytotoxics and highly potent compounds at Novasep.


Novasep has a dedicated regulatory team to provide the regulatory support and expertise required for the submission and maintenance of regulatory filings. Novasep can assist customers in drafting and submitting the CMC section of IMPDS, INDs, MAAs and NDAs; we can also file and maintain our own CEPs, ASMFs and DMFs.
Novasep has filed regulatory dossiers for about 40 APIs and formulations and manage approximately 200 DMFs and ASMFs with different authorities worldwide (the USA, Europe, Canada, Japan, Korea, etc.).
Our full quality and inspection track record is available upon request, contact us for more details or to assess you regulatory support needs

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