A small biotechnology company preparing its first Clinical Trial Application (CTA) in Canada and Investigational New Drug (IND) application in the United States faced significant challenges due to limited regulatory experience, lack of established submission processes, and insufficient internal resources for coordinating documentation and timelines.
Certara provided integrated project management and regulatory submission leadership, including strategic planning, cross-functional team alignment, risk management, real-time tracking tools, meeting facilitation, and region-specific authoring and publishing support. This collaboration enabled the client to successfully submit both applications on time, establish structured workflows for future use, and advance their product into first-in-human trials—helping to accelerate the delivery of much-needed therapies to patients.
Frequently Asked Questions (FAQs)
What were the client’s results after partnering with Certara?
The client successfully submitted both their CTA and IND on time, gained full visibility into the process, improved internal coordination, and established a submission framework they can use for future programs.
How did Certara support the client’s dual submissions?
We provided strategic submission planning, cross-functional coordination, document quality review, regulatory writing, and publishing support—plus real-time tracking tools and risk management strategies to keep the process on schedule.
Which Certara services were used in this project?
The engagement included project management, regulatory strategy, regulatory writing, document quality services, and regulatory operations support.
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IND Filing & CTA Submissions for Small Biotech FAQs
What is the difference between a Clinical Trial Application (CTA) and an Investigational New Drug (IND) application?
A CTA is the regulatory submission required to begin a clinical trial in Canada, while an IND is required in the United States. Both submissions ensure patient safety and regulatory compliance, but they have different formats, regional requirements, and review processes. A coordinated strategy is essential when preparing both in parallel to meet varying agency expectations.
Why is early clinical regulatory planning important?
Early planning helps ensure that all scientific, operational, and regulatory elements are aligned before submission. It reduces the risk of delays, enables better resource allocation, and ensures compliance with country-specific regulations.
What challenges do small biotechnology companies face when preparing their first CTA or IND?
Common challenges include a lack of internal regulatory experience, limited understanding of regional requirements, absence of established submission processes, and difficulty managing cross-functional timelines and deliverables.
How does integrated project management improve submission outcomes?
Integrated project management ensures visibility, accountability, and coordination across teams. It streamlines workflows, proactively addresses risks, and allows for structured, repeatable processes for future submissions.
