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.
The most useful platforms for regulatory support include Cosmetica Italia for cosmetics and SITOX (Italian Toxicology Society) for toxicology.
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
- R&D 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).
- Centralised electronic notification: for cosmetic products through the new CPNP – Cosmetic Products Notification Portal in line with the EC Cosmetic Regulation n.1223/2009.
- Scientific marketing and communication.
- Toxicological evaluation: (Safety Assessment) for ingredients and raw materials.
- Cosmetic Products Notification.
- 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
- Technical education (toxicology, microbiology, cosmetic testing, regulatory, ISO 22716, design) online and on site (Abich Academy).
- Customized education and training on the companies’ site.
- Assistance in the management of changes from 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
- Clinical data Evaluation Plan and Report (CEP e CER).
- Design and assistance as a CRO in post-marketing and pre-marketing clinical studies.
- Assistance in medical devices labelling according to ISO 15223, ISO 20417 (ex ISO 1041).
- Support and consulting for post marketing surveillance (PMS, PMCF e PSUR).
- Design and R&D for topical products; manufacturing of pilot batches.
- Customized regulatory consultancy.
- Validation of sterilisation methods.
- Technical training and education (product files, ISO 13485, sterilization, classification, MDR compliance etc) online and on site (Abich Academy).
Abich provides research, clinical data analysis, and regulatory consulting services for several fields including cosmetics, medical devices, supplements, natural products, active ingredients, raw materials, and toxicology.
