Regulatory
Receiving regulatory approval for your company's medical technology is a multi-year process that can cost millions of dollars. Your company will receive numerous inquiries and requests for information from regulatory representatives. How you interact with these representatives and the data you produce in response to their requests will determine whether or not a particular regulatory body will approve the marketing of your product. This is why it is vital to have a rigorous regulatory strategy in place before you embark upon your company-specific pathway.
1. Regulatory Strategy
The regulatory strategy and clinical study plan will determine which approval pathway your company chooses. We will review where your company is in its development plan and build the regulatory strategy accordingly.
2. Clinical Trial Design
TDA's trial architects will review your preclinical and biochemical studies and determine if any other clinical (real-world) data should be gathered to inform the drafting of your IND dossier in the Common Technical Document format. We will help you submit your final IND and assist you in responding to Requests for Information from regulatory authorities.
3. Document Retention
TDA will help you design and implement a robust document retention platform to house your product development reports and protocols, including your company's development master plan. TDA's audit experts can review your existing reporting and identify any data collection gaps that should be corrected for future development activities.
4. Advice Meetings
TDA will help you prepare for meetings with regulatory authorities. Our experts will work with your team to conduct a realistic assessment of the product's development plan by reviewing the strengths and weaknesses of each program and drafting strong arguments that can be defended with data and proven product development principles.
During the marketing approval process your company will interact with various regulatory bodies and their representatives. TDA's experts have decades of experience attending and presenting at these meeting. Whether you are scheduled for a pre-Investigational New Drug meeting (pre-IND), an end-of-phase-II, a Type A (dispute resolution), a Type B (before filing new clinical data), or a pre-501(k) meeting if your company is developing a device, we can help you put your best foot forward during these important developmental milestones.