Upon the completion of clinical studies, navigating the regulatory landscape is crucial for bringing your biologic or medical device to market. At BioMDg, we specialize in preparing 510(k) premarket notifications, including traditional, special, and abbreviated submissions. Our team ensures that all necessary documentation is meticulously crafted to meet FDA requirements, streamlining the approval process. Whether you’re seeking a swift pathway for devices that are substantially equivalent to existing products or a more in-depth review, we tailor our approach to fit your specific needs.
In addition to premarket notifications, we also provide comprehensive support for Design Dossiers and Technical Files required for CE Marking. Our experts are well-versed in the complexities of Premarket Approval (PMA) and Premarket Development Plans (PDP), guiding you through every phase of the application process, including amendments and supplements. If your product falls under biologics, we handle Biologic License Applications (BLA) and New Drug Applications (NDA), ensuring that your submissions are thorough and compliant. If you’re interested in exploring your options for regulatory pathways, contact us today to learn more about our tailored services.
Enhancing Your Submission Strategy with Data Analysis
Furthermore, our support extends beyond initial submissions to include clinical report writing, regulatory submissions, and preparation for panel meetings. We analyze your study data to provide insights that enhance your submission strategy and prepare you for critical discussions, such as the 100 Day Meetings with regulatory bodies. Additionally, we guide you through the process of obtaining Breakthrough Designation, which can expedite the development and review of your product, as well as Canadian Device License applications, ensuring compliance with both US and Canadian regulations. Our goal is to empower you with the knowledge and documentation needed to navigate these pivotal moments confidently. Don’t leave your product’s regulatory success to chance—get in touch today to find out how our consulting services can elevate your clinical outcomes and facilitate a smooth path to market.
Empowering Your Path to Market Compliance
Clinical – upon study completion:
- Analyze data
- 510(k) – Premarket notifications – traditional, special, abbreviated
- Design Dossiers and Technical Files for CE Marking
- PMA / PDP – Premarket approval applications, amendments and supplements
- BLA / NDA – Biologic License Application / New Drug Application
- Breakthrough Designation
- Canadian Device License Applications
- Write clinical report
- Regulatory Submissions
- Panel preparation
- 100 Day Meetings