Invaluable expertise in the new drug landscape to streamline your path to market.
Investigational New Drug (IND) and Clinical Trial Application (CTA)
At Senita, we understand the rigor and processes for developing investigational new drug applications (INDs) and clinical trial applications (CTAs). We work with our clients to implement the most appropriate strategy for achieving approval from the US FDA and other regulatory authorities.
Our Services:
Conduct a comprehensive assessment of our client’s product
Our assessment may include the product’s intended use, mechanism of action, and potential risks and benefits.
Develop a regulatory strategy
Based on our comprehensive assessment, we will create a strategy that outlines the necessary steps for a successful IND or CTA application.
Help prepare the IND or CTA submission
We compile all necessary data and information, complete the required forms, and review the necessary documents.
Resolve agency information requests
We help our clients by responding to questions and requests for additional information and addressing any concerns that regulatory agencies may have about the IND/ CTA submission.