registration of medical devices and cosmetics

... (PIF). MEDICAL DEVICES: Toxicological assessment of extractables, leachables, and nanomaterials, Biocompatibility assessment (ISO 18562), Biological evaluation (ISO 10993). PHARMACEUTICALS: Assessment of cross-contamination risk, Determination of occupational exposure band (OEB), Determination of acceptable daily exposure (ADE). DIETARY SUPPLEMENTS: Toxicological assessment of plant extracts, Determination of acceptable daily intake (ADI).

...manufacturing and packaging of own products or for third parties. Non-sterile pharmaceutical products: solid, semi-solid, and liquid forms such as powders, solutions, syrups, ointments, creams, gels, and shampoos. Cosmetic products, dietary supplements, medical devices, and biocides: semi-solid and liquid forms such as liquid soaps, shampoos, lotions, sprays, creams, gels, and ointments. Medgenix also conducts research.

... clinical studies - building up the files containing information about the products - we will support you with the correct declaration in compliance with the Cosmetics Directive, EU MDR & MDD Directive for Medical Devices, as well as with any documentation required for EU & outside EU registration of products Production - an industrial site devoted to manufacturing creams, vaginal ovules, suppositories, oral solutions, serums, lotions, milks etc. - compliance with GMP guidelines - filling in many types of primary packaging (suppositories, sachets, tubes, airless, bottles, sample tubes, jars etc.)...