Drug Substances & Products Manufacturing

Reusable medical devices

Nitrosamine impurities

SAXOCON can check your products for the presence of highly toxic nitrosamine compounds. According to a European Medicinal Agency (EMA) review under Article 5(3) of Regulation (EC) No 726/2004, all marketing authorisation holders in the EU are required to evaluate, and potentially test for, the presence of nitrosamines.

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Reusable medical devices

Unexpected particulate matter findings

With a SAXOCON service level agreement (SLA), you will have everything you need to analyse and evaluate the impact of deviations or non-conformances when sudden unexpected findings of particulate matter in, or in contact with, your drug products appear.

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Reusable medical devices

Safe equipment and systems

SAXOCON can help you ensure that any production equipment that comes into contact with drug substances or drug products is documented compliant with any regulatory requirements.

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Reusable medical devices

Manufacturing change control

SAXOCON provides services that let you maintain Good Manufacturing Practice (GMP) by understanding the impact of changes, deviations or non-conformance relating to ICH Q7, Q8, and Q9.

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Reusable medical devices

Cleaning validation support

SAXOCON helps you to establish and document Permitted Daily Exposure (PDE) in accordance with regulatory requirements for the manufacture of medicinal products in shared facilities.

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