Project Type: CMC Dossier for an Initial IND Submission
Product Type: Antibody-Drug Conjugate
Product Lifecycle Stage: Phase 1
Global’s Medical Writing Capabilities
01
Regulatory CMC Strategists to help navigate the complex regulatory landscape
02
CMC Technical Experts to guide process, formulation, and analytical development
03
Quality Experts to support phase-aligned cGMP compliance
04
Writers & Document Specialists to author submission-ready regulatory and technical documents
05
About the Client
The client was a clinical-stage biopharmaceutical innovator company focused on treating solid tumors with antibodydrug conjugates (ADCs).
About the Project
ADC development programs are inherently complex because they combine the technical challenges of small molecule and large molecule development into a single program. Additionally, this client had a small team of subject matter experts supporting the entire ADC pipeline. Due to the resulting resource constraints and an aggressive timeline, the client engaged with GLOBAL regulatory and CMC experts to author Module 3 for the initial IND and to provide strategic regulatory support for the program.
Global Solutions
- Create an end-to-end project plan based on the client’s current state and planned submission timeline.
- Perform a gap assessment of available source documents to proactively identify potential deficiencies in an initial IND.
- Develop a risk-based strategic remediation plan prioritizing potential clinical hold deficiencies.
- Author Module 3 with a complete data package and an appropriate level of detail by leveraging relevant CMC regulatory and writing expertise.
- Manage efficient document development throughout the process, including client reviews, copyediting, formatting, and eCTD publishing.
- Prepare recommended responses to potential Information Requests prior to submission.
Outcome
Our partnership yielded:
- A right-first-time IND that was submitted on time and received a Safe to Proceed letter with no Agency questions requiring immediate responses.
- A high-quality submission facilitated by collaborative project management that overcame the client’s resources challenges and complex network of thirdparty development sites.
- Integration of Agency feedback into ongoing development activities and alignment to phaseappropriate milestones