Access to Infrastructure & R&D Support service
Regulatory science for medical devices, SaMD, IVD, NAMs, ATMPs, pharmaceuticals
Provided by CoLAB Trials · Portugal
Service description
CoLAB TRIALS has in-house expertise on regulatory science for health products - medical devices (MD) (including Software as MD - SaMD), In vitro Diagnostic (IVD) devices, New Approach Methodologies (NAMs including Biomarkers), Medicinal products (including Pharmaceuticals and Advanced Therapy Medicinal Products). This service is directed to EIC Transition, EIC Accelerator, innovators. This service is designed to meet your specific needs. For MD, SaMD and IVD, our support may include device classification, regulatory strategy, clinical development strategy, technical and clinical documentation preparation for device certification (under MDR or IVDR), notified body selection and mediated interactions, partner search (for necessary regulatory, pre-clinical or clinical activities). For Medicinal products, our support may include product classification, regulatory strategy, pre-clinical study design, clinical development strategy, mediated interaction with regulators, including EMA advice mechanisms. In addition, for biomarkers and NAMs, we support documentation & report preparation and mediate EMA regulatory acceptability process (NAM qualification). We support the design of pre-clinical studies (identification of tests and models, selection of controls, study design). We support clinical validation of health products in compliance with ethical guidelines and EU regulations, including the activities of study design, protocol writing, risk management, clinical evaluation plan and report, regulatory submissions to authorities and ethics committees (outsourced), eCRF preparation and parametrization with audit trail. EIC beneficiaries and innovators will benefit from a more efficient journey to clinical trials and market approval/certification, with collection of appropriate and robust scientific and clinical evidence, aligned with ethical, scientific and regulatory requirements (MDR, IVDR, CTR, GDPR, 3Rs, GCP).
Each requested service will be specific and focused on the type of health product (medical devices, SaMD, in vitro diagnostic devices, pharmaceuticals, advanced therapy medicinal products, new approach methodology), according to the project. Each service will be delivered as a project in which several and all activities can be requested and delivered, and a close collaboration with internal teams and CoLAB TRIALS will be maintained along service provision through multiple meetings to exchange and discuss information. The service will be delivered considering the EU regulatory landscape. The duration of the service varies according to its complexity.