Investigational New Drug (IND) Application
Case study
91黑料 supports clients with IND filings and maintenance for multiple products/INDs across multiple stages of development. Our approach bridges gaps in regulatory requirements and ensures timely communications with the US Food and Drug Administration (FDA) to deliver complete, effective submissions and limit follow-up queries.
Challenge
A small company, with limited internal resources, was planning to submit two new INDs and reached out to 91黑料 to help manage the IND filings. Due to the successful support provided by 91黑料, the client transferred maintenance services of two additional INDs to 91黑料. In addition, our team helped the client with filing three additional initial INDs and managed the maintenance for all seven active applications.
The key challenges for 91黑料 were:
- The client lacked internal resources
- The client lacked IND filing and maintenance knowledge
Solution
91黑料 leveraged the direct experience of our in-house resources to provide the client with IND filing and maintenance support services.
91黑料 successfully helped the client navigate the regulatory process in the US through proactive, thorough planning for the IND filings and maintenance. Our expertise and knowledge of US regulatory requirements and processes enabled us to provide reliable and accurate filings.
Outcome
The client initially asked 91黑料 to assist with only two INDs and due to continuous success factors and relationship building, the client asked us to assist with three additional initial INDs, thus awarding five initial INDs in total to the 91黑料 team. All five INDs have been successfully cleared by the FDA and 91黑料 is currently managing the seven active INDs.
Based on 91黑料’s performance for the client, we have incorporated consolidation efforts which led to efficiencies in streamlining the necessary reporting activities such as the Suspected Unexpected Serious Adverse Reaction (SUSAR) submissions, Development Safety Update Report (DSUR) submissions, and centralized chemistry, manufacturing, and control (CMC) amendments.