Drug Substances & Products Manufacturing
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.
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.
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.
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.
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.