Strengthening IND Preparation Through Expert Nonclinical CTD Support

A small UK biotech developing a neuro-oncology-specific therapy was preparing for an IND submission and required extra support with their nonclinical documents.

Preparing the nonclinical components of an IND is a complex undertaking, especially when data originates from multiple studies, legacy sources, and external contributors.

For a growing UK biotech advancing a novel monoclonal antibody in pediatric oncology, Morula Health served as their regulatory writing partner to help transform diverse nonclinical information into a clear, compliant CTD Module 2.4 and 2.6.

They lacked an internal regulatory writing team and  previously relied on individual consultants but never worked with a strategic team capable of managing larger complex submissions.

This case study demonstrates how disciplined coordination, experienced regulatory writing, and the expertise of medical writers with extensive nonclinical CTD writing experience can bridge the gap between nonclinical and clinical CTD modules to meaningfully accelerate early-stage development. 

OVERVIEW

A UK‑based biotech developing a neuro‑oncology therapy was preparing for their first IND submission. With no internal regulatory writing team and previous reliance on individual consultants, they needed experienced support to manage multiple nonclinical documents, specifically CTD modules 2.4 and 2.6.

They discovered Morula Health through industry networks and sought a partner capable of both strategic guidance and hands‑on writing expertise.

CHALLENGE

Diverse Data Sources and Evolving Nonclinical Requirements 

The Biotech’s nonclinical program included a mix of legacy studies, newly generated data, and ongoing toxicology work. Several challenges emerged during planning and preparation of CTD Modules 2.4 (Nonclinical Overview) and 2.6 (Nonclinical Written and Tabulated Summaries):

• Nonclinical data originated from multiple eras and institutions, including historical studies from the early 2000s and recent toxicology and pharmacology evaluations.  

• Some studies had not been previously summarized, requiring fresh scientific interpretation and narrative development. 

• Timelines were tight, with the client targeting module completion by August and ongoing regulatory discussions influencing content needs.  

• Several external consultants were involved, creating a complex review workflow that needed unified coordination.  

• Additional literature and data sources extended the time needed to finalize certain modules, particularly pharmacokinetics.  

The Biotech needed a regulatory writing partner capable of integrating diverse scientific inputs, bringing together a fragmented team of subject matter experts, with a single focus: to support the clinical data already available and maximize the chances of IND approval.  

While their existing consultants were skilled, they lacked the bandwidth and coordination required for a multi‑document submission. The biotech needed:

• Writers with deep neuro‑oncology and nonclinical expertise

• A structured approach to manage timelines, dependencies, and evolving data

• Clear, consistent documentation aligned with regulatory expectations

• The flexibility to accommodate data that was not yet fully complete

THE SOLUTION

Integrated Regulatory Writing and Structured Program Management 

Morula Health assembled a bespoke team of experienced oncology medical writers who were also specialists in nonclinical module development. Together with the biotech’s Head of Regulatory Affairs, we established a strategic plan of action that accounted for data gaps and anticipated additional document needs. 

We deployed a lead regulatory writer supported by robust project management oversight to deliver clarity, consistency, and regulatory alignment.

1. Regulatory Driven Content Development 

Our writer collaborated directly with the Biotech's regulatory affairs lead and project manager to: 

• Structure Modules 2.4 and 2.6 according to CTD expectations and IND readiness. 

• Convert heterogeneous nonclinical reports into cohesive written and tabulated summaries. 

• Align key messaging with FDA’s expectations for pediatric oncology biologics, ensuring clarity around pharmacology, pharmacokinetics, and toxicology results. 

• Incorporate legacy data responsibly while highlighting newly completed studies, including rat toxicology work and additional binding studies.  

This ensured the final documentation accurately represented the scientific program while supporting regulatory strategy. 

2. Clear Review Pathways and Stakeholder Alignment 

Given the number of external consultants involved, Morula Health established: 

• Organized comment resolution meetings (CRMs) to consolidate feedback and reduce rework.  

• Defined reviewer responsibilities to support efficient draft cycles. 

• SharePoint based access and version control to streamline reviewer input.  

• Predictable milestone tracking across modules, ensuring transparency for all contributors. 

These measures reduced friction and helped maintain a consistent document narrative. 

3. Adaptive Delivery in Response to Evolving Data and Priorities 

The nonclinical program evolved throughout development: 

• New literature and unexpected depth of data extended module timelines, especially in pharmacokinetics.  

• Additional studies became available during drafting, requiring integration into ongoing workstreams. 

• CRM schedules were updated in real time to keep modules moving through review.  

Morula Health adapted continuously, supporting the client’s shifting regulatory milestones without loss of momentum. 

Our approach included:

• QC checklists and SOPs tailored to CTD modules to ensure consistency and compliance

• Defined style guides to harmonize outputs across writers and documents

• Flexible timelines that aligned writing activities with data readiness

• Scalable support, allowing multiple writers to be onboarded as scope expanded

• Proactive communication and critical review, elevating the clarity and regulatory quality of each submission component

Two months after scoping, once preliminary data was available, the project launched smoothly. As new requirements emerged mid‑project, the team adapted without impacting timelines or budget.

OUTCOME

A Cohesive, Submission Ready Nonclinical CTD Package 

Morula Health delivered polished, compliant, high‑quality nonclinical documents that strengthened the biotech’s IND submission package. The partnership resulted in strong regulatory and operational outcomes: 

✔ High quality, CTD compliant nonclinical modules 

Modules 2.4 and 2.6, including pharmacology, pharmacokinetics, and toxicology summaries, were completed, reviewed, and fully QC Checked.  

✔ A unified scientific and regulatory narrative 

Legacy reports, new study data, and supporting literature were harmonized into a coherent IND ready storyline. 

✔ Streamlined cross functional collaboration 

Centralized CRMs, consolidated feedback cycles, and structured reviewer engagement significantly reduced rework and improved clarity. 

✔ Maintained progress despite increased scope 

Even as additional reports and literature extended effort on some modules, total project momentum remained strong, supporting the Biotech’s overall IND timeline.  

✔ A scalable documentation model 

The systems, workflows, and processes established for this project can be used for future CTD expansions and amendments. 

The Biotech highlighted:

• Exceptional quality of nonclinical documentation

• Confidence in their regulatory materials

• Appreciation for clear communication, strategic guidance, and responsive support

• Interest in continuing collaboration for future submissions

Key Takeaway for Biotech Organizations

For small or growing biotechs, strategic outsourcing can unlock the operational and scientific capacity needed to progress toward key milestones, without the overhead of building a full internal writing team.

Morula Health’s blend of flexibility, nonclinical expertise, and rigorous process enabled this neuro‑oncology biotech to move forward with confidence.

Your IND Partner in Growth

A Regulatory Partnership That Delivers Confidence and Clarity 

By integrating expert CTD authorship with proactive project oversight, we help biotech organizations turn diverse data into regulatory ready documentation, strengthening their submissions and accelerating their path to clinic. 

Morula Health integrates with your team to reduce pressure, streamline processes, and elevate the scientific standard of your submission. Get in touch to learn more.

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