Regulatory & Licensing Consulting
Our goal is to become the preferred consulting firm for FDA regulatory compliance and product development in the biotech, pharmaceutical, and medical device industries. We are dedicated to enhancing public health through our work.
We don’t just meet the minimum regulatory standards; we work alongside you as a collaborative partner. We recognize the importance of adhering to FDA regulations in ensuring that safe and effective products reach patients. From start to finish, our team of experienced professionals combine their scientific knowledge and regulatory expertise to deliver a thorough solution to meet your needs.
We provide a wide range of consulting services.
Clinical trial applications
One of our primary areas of focus is clinical trial applications. We understand the critical importance of efficiently and effectively managing the application process to gain regulatory approval for your clinical trials. Our team of experienced professionals works closely with you to prepare and submit robust applications that comply with all relevant regulations and guidelines.
At Gene Bio Medical, it is important to comply with Good Manufacturing Practice (GMP) regulations and ISO 13485:2016 standards for ensuring the safety, efficacy, and quality of your products. Our team of experts is committed to helping you maintain compliance with these regulations and standards by providing comprehensive consulting services.
Medical Device licenses, Product submissions and applications
We also specialize in assisting with medical device product submissions and applications Medical device License (MDL), Medical Devices Establish License (MDEL). We understand the unique challenges associated with gaining regulatory clearance or approval for medical devices. Our team of regulatory experts is well-versed in the requirements and processes involved in submitting comprehensive applications for various types of medical devices.
We prepare and provide submission support during Health Canada review for Class II, III and IV Medical Device Applications. In addition, we will confirm the risk-based classification and provide submission support during the Health Canada review. As a part of our service, we will advise on any regulatory compliance issues which may be of concern during review. Our Medical Device Regulatory Consulting team possesses the expertise to assist you throughout every step of the FDA’s medical device regulation process.
Site regulatory compliance applications
We work closely with Health Canada, FDA, and CE to ensure that your facility license is up-to-date and in compliance with all relevant regulations. Our team can assist with updating, modifying, and notifying these regulatory bodies of any changes to your facility or products.
We help host or assist with other Inspections/Audits from Start to Finish.
- Third-Party (Supplier)
- Internal (Self-Inspections)
Our other Services
Gene Bio Medical offers valuable assistance in the following areas:
- Determining the regulatory pathway for devices and combination products that include device components, such as by submitting 513(g) requests, Requests for Designation (RFD), and pre-RFDs
- Identifying and evaluating performance data required for premarket submissions, which may involve pre-submissions
- Providing support for FDA’s Investigational Device Exemption (IDE) and other clinical study requirements
- Preparing or reviewing various premarket submissions, including:
- 510(k) Premarket Notifications
- De Novo requests for Automatic Class III Classification
- Humanitarian Use Designations (HUD) and Humanitarian Device Exemptions (HDE)
- Premarket Approval (PMA) Applications, Supplements, and Notices
- Responding to FDA’s Requests for Additional Information related to these submissions
- Providing guidance on postmarket requirements, including:
- Medical Device Reports
- Corrections and removals (recalls)
- Labeling contents and claims
- Device modifications
Gene Bio Medical is committed to providing exceptional consulting services to our Canadian and International partners in the healthcare industry. Our goal is to help you navigate the complex regulatory landscape of the healthcare industry and ensure that your products and services meet the highest standards of quality and safety.
With Gene Bio Medical as your partner, you can be confident that you are receiving the best possible consulting services to support your business and focus on bringing innovative and life-changing products to market.
