Aware of the complexity of the challenges you are facing today – and predicting those of tomorrow – we support you in the growth and development of your business along your product’s entire lifecycle. Our aim is to provide you with high-quality and customized regulatory support, digital solutions and full-service CRO assistance, capable of satisfying your business goals, time and budget requirements, while ensuring regulatory compliance.
Aware of the complexity of the challenges you are facing today – and predicting those of tomorrow – we support you in the growth and development of your business along your product’s entire lifecycle. Our aim is to provide you with high-quality and customized regulatory support, digital solutions and full-service CRO assistance, capable of satisfying your business goals, time and budget requirements, while ensuring regulatory compliance.
Determined to see the success of your projects, we identify the most reliable pathway for product development, providing quality consultancy for the preparation and implementation of Quality Management Systems in compliance with standard ISO 13485, regulatory consultancy for the preparation and maintenance of Technical Documentation and Clinical Evaluations in accordance with MDR and IVDR requirements, and full-service support for clinical trials within the EU.
Furthermore, thanks to our strategic partnership with 1LAB, a preclinical laboratory specialized in in vitro testing, we design ad hoc experimental protocols for topical, bioabsorbable and cardiovascular medical devices, providing important information on the safety and performance of the products for compliance with R&D and regulatory requirements.
Determined to see the success of your projects, we identify the most reliable pathway for product development, providing quality consultancy for the preparation and implementation of Quality Management Systems in compliance with standard ISO 13485, regulatory consultancy for the preparation and maintenance of Technical Documentation and Clinical Evaluations in accordance with MDR and IVDR requirements, and full-service support for clinical trials within the EU.
Furthermore, thanks to our strategic partnership with 1LAB, a preclinical laboratory specialized in in vitro testing, we design ad hoc experimental protocols for topical, bioabsorbable and cardiovascular medical devices, providing important information on the safety and performance of the products for compliance with R&D and regulatory requirements.