Our Regulatory Affairs team supports the customer through all stages of a product’s lifecycle, from preclinical assessment to pre-market clinical trials, all the way to CE marking and post-market surveillance activities, with an efficient and cost-effective approach, alongside with regulatory compliance.

The regulatory team offers expertise, rigor and a solid and continuous update on the regulatory frameworks, guidelines and technical standards that regulate the sale of products belonging to different product categories: medical devices, in vitro diagnostic devices, drugs, food supplements.

Medical Devices

• Support in the correct classification of a medical device and identification of applicable requirements
• Gap analysis and transition from MDD to MDR/IVDR
• Assistance in drafting technical documentation according to MDR Annex II and III, including CEPs, CERs and ARs 
• Support for Biological Evaluation and biocompatibility tests (BEP and BER)
• Support in drafting post-marketing surveillance documentation (PMS plan & report, PMV, PSUR, PMCF plan & report)
• Bibliographic research
• Customised MDR/IVDR training

Drugs

• Regulatory Strategy
• Strategic advice
• Clinical trial applications
• Regulatory activity and preparation of submission package, FDA 510(k) pre-market notifications
• Scientific literature review
• Real World data collection strategies
• Orphan drugs designation 
• Paediatric investigation plan

The Quality team offers consolidated expertise by supporting our clients in the implementation and maintenance of the Quality Management System (QMS) according to ISO 9001, ISO 27001 and ISO 13485 standards. The QMS is essential for companies wishing to bring their products to market.

An integrated data and information system must be implemented to manage documents, records, product information, risks, and other elements of the QMS with the aim of achieving higher quality.

• Quality System design according to ISO 13485 Standard and the Medical Device Regulation (MDR) 2017/745 and (IVDR) 2017/746
• MDSAP system (Medical Device Single Audit Program)
• QMS Gap Analysis for transition from MDD to MDR
• Customised training on ISO 9001, ISO 27001 and ISO 13485
• Support in obtaining certifications according to ISO 9001, ISO 13485, ISO 27001 
• Assistance in choosing suitable Notified Bodies for certification of your device 
• Interaction with Notified Bodies and Competent Authorities during certification processes and audits 
• Review of quality documentation and Gap Analysis
• Support in carrying out internal audits and managing preventive/corrective actions (CA/PA)
• Assistance in the identification, evaluation, qualification and monitoring of suppliers