We provide full regulatory support services to guide your Company in the pre-market and post-market phases
We provide high quality and reliable regulatory services to support your company at all stages of the product’s lifecycle, both in the pre-market and post-market phases.
Strong on our expertise in medical devices, in vitro diagnostics, pharmaceuticals and food supplements, we support our clients with EU and US regulatory submissions, with focus on all types of medical devices, including substance based and combination products.
A well-designed regulatory strategy is the base to a successful pathway to product certification: we translate medical device regulations into concrete customized regulatory strategies, in compliance with European and International regulations, considering development costs, development cycles and profitability concerns.
We assist our clients with Technical Documentation assembling, with an extensive experience in developing clinical evaluation reports, biological evaluations, post market clinical follow ups and post market surveillance activities and in identifying real world data collection strategies, in the pre-market and post-market phases, with the support of digital and innovative solutions.
We provide full regulatory support services to guide your Company in the pre-market and post-market phases
We provide high quality and reliable regulatory services to support your company at all stages of the product’s lifecycle, both in the pre-market and post-market phases.
Strong on our expertise in medical devices, in vitro diagnostics, pharmaceuticals and food supplements, we support our clients with EU and US regulatory submissions, with focus on all types of medical devices, including substance based and combination products.
A well-designed regulatory strategy is the base to a successful pathway to product certification: we translate medical device regulations into concrete customized regulatory strategies, in compliance with European and International regulations, considering development costs, development cycles and profitability concerns.
We assist our clients with Technical Documentation assembling, with an extensive experience in developing clinical evaluation reports, biological evaluations, post market clinical follow ups and post market surveillance activities and in identifying real world data collection strategies, in the pre-market and post-market phases, with the support of digital and innovative solutions.
We own strong expertise across therapeutic areas
Our structured and multidisciplinary regulatory team has a broad focus across therapeutic areas with expertise in a wide range of medical fields.
We own strong expertise across therapeutic areas
Our structured and multidisciplinary regulatory team has a broad focus across therapeutic areas with expertise in a wide range of medical fields.
We offer turn-key services
We support our clients 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.
Our regulatory services include:
We offer turn-key services
We support our clients 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.
Our regulatory services include:
We ensure continuous regulatory compliance
Medical device regulations are becoming increasingly difficult, making it harder to deal with changing requirements. Our Regulatory Intelligence department ensures an up-to-date vision on regulatory requirements, constantly adapting our approach and documentation accordingly in order to ensure continuous regulatory compliance and anticipating potential issues.
We assist in the liaison with NBs and CAs
We assist our clients with tailored assistance in negotiating with national and international Notified Bodies, FDA and international regulatory agencies and Competent Authorities.
We prepare and submit reviewers-friendly technical documentation, helping clients to go through the interaction processes with NBs or CAs quickly and effectively.
Working with international and start-up companies on new product developments and interacting with EU Competent Authorities and Notified Bodies, gave us the opportunity acknowledge that, the understanding of the technology and of the benefit that such technology may have for patients in the end is key for granting Regulatory Authorities approvals. This is confirmed by our 100% of success rate obtained with the certifications of more than 300 different medical devices.
We ensure continuous regulatory compliance
Medical device regulations are becoming increasingly difficult, making it harder to deal with changing requirements. Our Regulatory Intelligence department ensures an up-to-date vision on regulatory requirements, constantly adapting our approach and documentation accordingly in order to ensure continuous regulatory compliance and anticipating potential issues.
We assist in the liaison with NBs and CAs
We assist our clients with tailored assistance in negotiating with national and international Notified Bodies, FDA and international regulatory agencies and Competent Authorities.
We prepare and submit reviewers-friendly technical documentation, helping clients to go through the interaction processes with NBs or CAs quickly and effectively.
Working with international and start-up companies on new product developments and interacting with EU Competent Authorities and Notified Bodies, gave us the opportunity acknowledge that, the understanding of the technology and of the benefit that such technology may have for patients in the end is key for granting Regulatory Authorities approvals. This is confirmed by our 100% of success rate obtained with the certifications of more than 300 different medical devices.
We design and perform tailored training programs
Our team of Regulatory Affairs Managers and Specialists are qualified by some of the most important Notified Bodies to support medtech companies in training activities within the Regulatory field, with focus on the requirements highlighted in the European Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostics Device Regulation (IVDR) 2017/746.
We support our clients with tailor made on-site and off-site training programs that focus on company’s specific needs on a wide range
of Regulatory aspects.
We design and perform tailored training programs
Our team of Regulatory Affairs Managers and Specialists are qualified by some of the most important Notified Bodies to support medtech companies in training activities within the Regulatory field, with focus on the requirements highlighted in the European Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostics Device Regulation (IVDR) 2017/746.
We support our clients with tailor made on-site and off-site training programs that focus on company’s specific needs on a wide range
of Regulatory aspects.