Assistance for exporting to EU

Compliance of a cosmetic product to European Regulation Complife technical regulatory team assess the full compliance of a cosmetic product to European Regulation 1223/2009, offering support in each step of the product conformity evaluation from composition check, labelling revision, PIF drafting and product notification on CPNP (Cosmetic Product Notification Portal). Complife Support Line+39 0382 25…

Stability test

Stability test: The purpose of stability testing (also according to ICH Guide Lines) of products is to ensure that a new or modified product meets the intended physical, chemical and microbiological quality standards as well as functionality and aesthetics when stored in certain set conditions. These studies can be also used to determine the “Period…

Quality control methods

Quality control methods: Set-up, validation and transfer of analythycal methods for in-process control and quality control of ingredients, bulk and semifinished products, finished products. Complife Support Line+39 0382 25 504Tests & AnalysisEfficacy TestsSafety TestsChemical AnalysisMicrobiological Tests Markets Cosmetics Medical Devices Nutrition Household Products Get more info about this test Discover how your dedicated expert Dr.…

Microbiological Quality control

Microbiological Quality control : Microbiological control is a relevant regulatory requirement to asses the safety of manufactured produtcs. Microbiological quality control is carried out according to updated official methods (ISO, EU/USP Pharmacopoeia, CTFA guidelines, etc, multinational guidelines) for ingredients, bulk, finished product, packaging components: Microbiological controls according to ISO standards Microbiological controls according to Eur…

Chemical Quality control analysis

Chemical Quality control analysis: A wide range of technical competences and expertise, combined with high standard equipments (HPLC, GC-MS, AA etc.), allows analytical testing of active ingredients and/or impurities either by official or taylor made protocols. Preservatives content Sunscreens (Cosmetic) active ingredients titration Regulated ingredients verification Impurities detection and levels/quantification Heavy metals traces Process water…

Reproductive toxicity

Reproductive toxicity: A set of in vitro testing for the reproduction risk assessment is performed, basing on assisted reproduction techniques, such as the in vitro oocyte maturation and fecundation assays on bovine model. In vitro maturation test: an assay reproducing the process of oocyte maturation, which corresponds to the pre-ovulatory in vivo phase that allows…

Ecotoxicity

Ecotoxicity: These assays are aimed at evaluating the environment risk hazard of substances, involving a number of different terrestrial and aquatic bioindicators (toxicity to algae Pseudokirchneriella subcapitata – OECD 201, crustacean Daphnia magna – OECD 202, fish Brachidanio rerio – OECD 203) and Biodegradability testing (OECD 301 and 306) Complife Support Line+39 0382 25 504Tests…

Acute Toxicity

Acute Toxicity: Acute systemic toxicity testing concerns the assessment of the systemic toxic effects of a single dose or multiple doses of a product by a particular route (oral, dermal, inhalation). BALB 3T3 NRU cytotoxicity in vitro assay is useful to estimate starting doses for acute oral systemic toxicity tests. Officially accepted in vivo tests…

Sensitization

Sensitization¬†efficacy is assessed using different techniques: Sensitization tests are useful to assess whether the product in exam may cause adverse effects involving immunological mechanisms; in vitro methods are currently under validation process. The human Cell Line Activation Test (h-CLAT) quantifies the induction of protein markers on the surface of THP-1 cell lines after exposure to…

Skin Irritation and Corrosion

Skin Irritation and Corrosion: Topical exposure to chemicals can lead to adverse skin effects. Depending on the severity and reversibility of the response it is possible to distinguish between skin corrosion and irritation. Corrosive substances irreversibly damage the skin, while irritant substances lead to a reversible local inflammatory reaction. In vitro test methods, including assays…