Marketing Submission
The premarket submission phase involves preparing and submitting comprehensive data to regulatory authorities, demonstrating the combination product’s safety, effectiveness, and compliance with applicable requirements.
US
Covita Health Partners provides comprehensive U.S. marketing submission support, including 510(k), De Novo, PMA, and HDE submissions. For drug or biologic-led combination products we can support the development of 3.2.R or 3.2.P Container Closure for the device constituent, as well as any other associated combination product-related test documentation. We also leverage our deep experience in FDA interactions to serve as a strategic liaison between your company and the agency, facilitating clear, effective communication throughout the process.
EU
Our team provides end-to-end support for EU marketing submissions, including the preparation of technical files or design dossiers required for CE marking device-led combination products in accordance with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). This includes the development of robust Clinical Evaluation Reports (CERs). With our deep understanding of EU regulatory frameworks, we help streamline the path to CE marking and maintain compliance throughout the product lifecycle. For drug or biologic-led combination products we can support the development of 3.2.R or 3.2.P Container Closure for the device constituent, as well as any other associated combination product-related test documentation.
Canada
We can support your product through the process of obtaining a Medical Device License (MDL) for your device-led combination product in Canada. For drug or biologic-led combination products we can support the development of 3.2.R or 3.2.P Container Closure for the device constituent, as well as any other associated combination product-related test documentation. We provide strategic guidance and hands-on support in preparing and submitting the required documentation in accordance with Health Canada’s regulatory requirements, helping you navigate the process efficiently and position your product for a successful product launch.
UK
If you are pursuing UKCA marking for your device-led combination product, our team can support the preparation of a comprehensive technical file or design dossier in accordance with MHRA requirements, helping ensure a smooth and compliant path to market in the UK. For drug or biologic-led combination products we can support the development of 3.2.R or 3.2.P Container Closure for the device constituent, as well as any other associated combination product-related test documentation.
Rest of World (ROW)
A technical file or design dossier is required to obtain marketing authorization for entry into most global markets. In some regions, proof of regulatory approval in major markets, such as the U.S. or EU, may be leveraged to streamline approval in smaller or emerging markets. With deep international regulatory expertise, Covita Health Partners can help you navigate these varied requirements and determine the most efficient path to global market entry.