Biochem Consulting

Medical Devices

• Regulatory compliance alignment from Council Directive 93/42/EEC to EU Regulation 2017/745 MDR;

• Preparation and updating of technical documentation for medical devices in accordance with EU MDR 2017/745 and IVDR 2017/746;

• Clinical Evaluation Report drafting compliant with MDR 745 – CEP and CER;

• Biological Evaluation Plan and Report drafting – BEP, BER according to ISO 10993;

• Assumption of the role of Regulatory and Quality Assurance Responsible Person;

• Risk analysis according to ISO 14971;

• Quality management system UNI CEI ISO 13485;

• Consultancy and support for CE marking of class IIa, IIb, and III medical devices;

• Usability assessment of medical devices pursuant to IEC 62366:2015;

• Evaluation of medical devices incorporating software;

• Evaluation and justification of ADME testing;

• Registration of medical devices in Eudamed and assignment of UDI codes;

• Support during regulatory inspections;

• Registration in the medical device databases and registries;

• Post-market surveillance and vigilance of medical devices;

• Borderline medical devices.

Food Supplements

• Technical support on labeling compliance, composition, and claims for dietary supplements;

• Notification procedures to the Ministry of Health;

• Drafting of technical-scientific justifications for supplements containing botanical ingredients;

• Certificates of Free Sale;

• Registration as Food Business Operator (FBO);

• Authorization of manufacturing and/or packaging establishments;

• Training courses;

• Authorization procedures for Novel Food before the European Commission.

Quality Management Systems (QMS)
The Biochem ISO & Quality team provides robust support in analyzing critical aspects related to process management, aiming to verify and assess their compliance with current regulatory standards. The team is responsible for the design, implementation, and maintenance of a management system tailored specifically to the company’s unique characteristics.

Biochem itself adopts an internal Quality Management System (QMS) based on the ISO 9001 standard, certified for the services provided.

Our Principal Services:

ISO 9001:2015 defines a Quality Management System (QMS) aimed at maximizing the quality and effectiveness of products and services.
ISO 13485:2021 is a Quality Management System, independent from ISO 9001, specifically applicable to Medical Devices and designed in compliance with relevant regulations.
ISO 22716:2008 is the GMP standard for Cosmetics, defining principles for the implementation of Good Manufacturing Practices in the production, storage, packaging, and warehousing processes.
The Gender Equality Certification, in accordance with the UNI/PdR 125:2022 guideline, highlights organizations’ commitment to implementing change aimed at achieving gender parity in the workplace.

Consulting Services

Expert consulting in regulatory compliance, method validation, and technology transfer to help optimize your operations and strategies.

Regulatory Affairs – Pharmaceuticals

• Preparation of regulatory dossiers in electronic eCTD format;

• Drafting of applications, variations, extensions, and renewals of Marketing Authorization (MA) codes;

• Company accreditation before AIFA (Italian Medicines Agency) – SIS Code;

• Support and management of CE marking processes;

• Regulatory procedure management with competent authorities (AIFA, Ministry of Health);

• Registration of pharmaceuticals, cosmetics, food products, and medical devices in national and European databases;

• Readability testing of patient leaflets;

• Usability testing and dose delivery evaluation.

Cosmetics

• Design and development of new formulations, preparation of technical data sheets for components;

• Verification of Certificates of Analysis (CoA), batch records, and ingredient lists;

• Preparation of the Product Information File (PIF);

• Support to companies and liaison with Notified Bodies to ensure compliance with requirements for obtaining ISO 22716 GMP certification;

• Second-party audits verifying that manufacturers (in case of outsourcing) implement procedures compliant with EN ISO 22716, the GMP reference standard for the cosmetic sector;

• Cosmetovigilance (collection of data for the evaluation of adverse reactions, causality assessment, reporting of serious undesirable effects to Authorities, and potential PIF updates);

• Requests for Certificates of Free Sale (CFS), required for export outside the EU;

• Support for laboratory analyses necessary for the safe commercialization of cosmetic products (patch tests, challenge tests, stability, and shelf life studies, etc.).