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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.

The challenge

A small biotechnology company preparing its first CTA in Canada and an IND application in the U.S. faced several hurdles due to limited internal experience. These regulatory submissions—required to initiate clinical trials—vary by region and involve complex, country-specific expectations.

Key challenges included:

  • Limited understanding of regional regulatoryrequirements
  • No established processes for planning, tracking,or submission management
  • Lack of internal expertise to coordinatedocumentation and timelines

Submitting CTAs and INDs involves aligningscientific, operational, and regulatory functionswhile ensuring compliance with evolving globalstandards. To move forward confidently, the clientrequired experienced submission leadership andend-to-end project management support.

The solution

To address these challenges, the client engagedCertara to provide comprehensive projectmanagement and regulatory submission leadership.

Our support included:

Strategic Planning & Leadership: Defined thesubmission strategy and aligned cross-functionalteams.

Project & Risk Management: Structured documentworkflows and proactively addressed risks usingSmartSheet.

Real-Time Tracking Tools: Implemented dashboardsand timelines to track progress and improve visibility.

Cross-Functional Meeting Management: Ledmeetings to ensure accountability and drive timelyexecution.

Authoring & Regulatory Operations: Delivered high-quality submission documents and supported region-specific publishing.

The impact

On-Time Submissions: Successfullysupported the submission of a CTA in Canadaand an IND in the United States.

Improved Visibility & Coordination: Real-timetracking and meeting leadership enabled fulltransparency and stakeholder alignment.

Streamlined Workflows: Established astructured, repeatable process the client canuse for future submissions.

By leveraging Certara’s regulatory expertise andproject management infrastructure, the clientconfidently navigated two major submissions—advancing their product into first-in-human trialsand ultimately helping to bring much-neededtherapies 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.

Contact the Certara team


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.