Regulatory Services
a. Pre-IND Discussions with FDA:
In the early stages of IND application preparation and study protocol planning, engaging in pre-IND consultations with the FDA can provide valuable insights.
Sunsecure identifies pertinent questions that warrant FDA consultation, collaborates with clients to compile the pre-IND package, and participates in meetings with Regulatory Agencies as needed.
b. IND Submission Assistance to FDA:
Complying with FDA-specified IND application formats is paramount. Sunsecure offers templates and support to determine essential content for the IND package.
We offer additional aid in crafting the informed consent document and establishing a Data Safety Monitoring Plan (DSMP).
c. Annual Reports and FDA Amendments Assistance:
As studies progress, ensuring adherence to the approved protocol is the responsibility of the Regulatory Sponsor. Protocol changes are submitted to the FDA via amendments, a process Sunsecure facilitates.
Even in the absence of protocol changes, regulations mandate submitting annual reports to the FDA. Sunsecure guides Regulatory Sponsors through reporting milestones and report preparation.
d. Safety Reporting:
Timely reporting of Serious Adverse Events is pivotal for ongoing trial operation. Sunsecure supports researchers/clients in adhering to proper reporting protocols.
Diverse categories of adverse events exist, each with distinct timelines for report submission based on severity.
e. Expanded Access Guidance:
The FDA's Expanded Access Program enables qualified physicians to provide investigational drugs or devices outside clinical trials. Specific criteria must be met, and coordination with the therapeutic provider is vital.
For patients who would benefit from an investigational product lacking current approval and no available clinical trial, the Expanded Access program serves as a solution.
Sunsecure offers guidance for completing requisite FDA forms and navigating the entire process involved.
Our Regulatory Services encompass a comprehensive range of support, ensuring compliance, streamlined reporting, and proper engagement with regulatory bodies. At Sunsecure, we take pride in guiding you through the intricate landscape of regulatory requirements, helping you navigate with confidence.
