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Nos certifications
Our qualifications
Chemineau quality policy
Chemineau quality policy is built and driven with 2 main objectives: regulatory compliance and customer satisfaction. Manufacturing regulatory status can fall into Chemineau responsibility depending on the project.
Chemineau follows pharmaceutical cGMP rules. The pharmaceutical plant of Chemineau is regularly audited by ANSM (French Authority)
We are ISO 13485: 2016 certified for conception, development and associated services, manufacturing and sale of Medical Devices in form of gel, cream, ointment, powder, suspension, and solution, and packed in aerosol, bottle, tube, jar and airless system.
We obtained and are maintaining CE mark, as a Manufacturer for these kinds of Medical Devices: isotonic sea water nasal spray, hypertonic sea water nasal spray, hypertonic with chamomila and aloe vera water extract sea water nasal spray, hypertonic with eucalyptus water extract sea water nasal spray, nasal fluidifying solution, and intimate lubricating gel.
Our Notified body is the LNE GMED.
The quality management system of Chemineau Labs allows us to implement each customer requirement thanks to specific procedures built from MA Dossier, Technical Dossier, or Customer requirement.