Consultancy

Abich provides experimental research services using innovative integrated technologies, as well as specific consulting activities: bibliographical evaluation, clinical data analysis and toxicological assessment for cosmetics, medical devices, supplements, natural products, active ingredients, and raw materials.

One of Abich’s strong points in the consulting field is the regulatory support it provides while keeping the customers’ and partner companies’ technical documents constantly updated.

Consultancy services offered by Abich:

• Product formulation and development: cosmetics and medical devices;
• Technical reports, risk analysis and drawing up of ER table (essential requirements): for medical devices, in line with the Directives EU 93/42/EEC and 2007/47/EC;
• Clinical data analysis: through bibliographical analysis in line with the UNI EN ISO 14155 standard;
•  Assistance in registration in the EUDAMED data bank for medical devices manufacturers and for products;
• Research and development projects and support for experimental patents;
• Technical dossiers of cosmetic products: (PIF – Product Information File) in line with the European Cosmetic Regulation 1223/2009;
• Regulatory assistance: for import/export and registration of new cosmetic products;
• Cosmetic Product Safety Report according to Regulation (CE) 1223/2009; with signature of a European Registered Toxicologist (ERT);
• European cosmetic product notification: Electronic notification for cosmetic products through Cosmetic Products Notification Portal according to EC Cosmetic Regulation n.1223/2009;
• Scientific marketing and communication;
• Toxicological evaluation: (Safety Assessment) for ingredients and raw materials.
• Development of extraction methods for botanicals;
• Assistance for cosmetic labelling, according to Regulation (CE) 1223/2009, and environmental labelling;
• Assistance for new cosmetic plants and laboratories start-up. Safety Assessment for ingredients and raw materials;
• INCI assignment for new raw materials, MSDS writing;
• Validation of methods and procedures for cleaning and sanitization of premises, equipment and plants;
• Assistance in the management of changes from European Directive CEE 93/42 (MDD) to Regulation (UE) 2017/ 745(MDR);
• Support to manufacturers for the feasability of new medical devices according to MDR;
• Toxicological and Pharmacokinetic evaluations (ADME) on bibliographic data with the signature of a European Registered Toxicologist (ERT);
• Assistance as Person Responsible for the Regulatory Compliance (PRRC) ex art. 15 MDR;
• Biological Evaluation Plan with a chemical and biological testing strategy and Biological Evaluation. Report (BEP and BER) according to ISO 10993-1;
• Technical file according to annex II MDR;
• Risk assessment according to ISO 14971;
• GSPR Table redaction;