Technical documentation of medical devices

Technical documentation of medical devices Complife expert team offers support to check the completeness of the technical documentation, a guidance to manage the transition to the new Regulation as well as support to define the chemical-physical characterization of DM and Biocompatibility testing plan. Complife Support Line+39 0382 25 504What we doServicesConsulting & RegulatoryTests & Studies…

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…

Shelf-life determination

Shelf-life determination is assessed using different techniques: Wrinkle surface is measured using a real 3D camera, while skin surface properties are measured using bioengineering techniques. Instrumental evaluations may be associated with clinical/dermatological assessment. Claims Anti ageing/wrinkle efficacy Anti wrinkle effect (after single product application) Improvement of skin smoothness Other techniques Skin moisturizing Skin elasticity Clinical…

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…

Process control

Process environment and equipment control as a primary tool for risk assesment: production equipment and environment have to be managed and controlled to minimize risks of contamination. According to GMP, risk assessment should cover: air handing system special enviroments cleanliness and sanitary conditions Cleaning validations for equipments and production facilities Air and water quality monitoring…

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…

Quality control analysis

Quality control analysis: In close collaboration with our customers’ Quality Control and Quality Analysis Managers, we are a reliable and certain reference for companies who like to think of us as “their own” testing laboratory, helping to set up and carry on the most appropriate quality control plans for raw materials, bulk, packaging components, finished…