Co-Labb Supports Blue Horizon International’s FDA Pre-IND Submission with Regulatory Writing

Elizabeth Mehling, Co-Founder, Blue Horizon International

Blue Horizon International (BHI) is a global leader in stem cell therapy, operating clinics worldwide. Their innovative treatments focus on advancing regenerative medicine, and they have built a reputation for delivering cutting-edge healthcare solutions. As BHI expanded its global footprint, they sought to take their research to the next level by pursuing U.S. regulatory approval for their therapies.

The Challenge

As BHI accumulated a wealth of patient data from its international clinical sites, it aimed to secure FDA approval in the U.S. to further validate its stem cell treatments. This required submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), a notoriously complex and demanding process. The IND application involves substantial technical and regulatory writing, clinical trial design, and strategic regulatory advice.

BHI needed a partner capable of handling the intensive writing requirements and regulatory complexities while guiding them through the IND pathway. They also required expert advice on clinical trial design and how to align their international data with U.S. regulatory standards.

The Solution

Co-Labb partnered with BHI to provide end-to-end support for their Pre-IND application process, ensuring that each step was meticulously handled to meet FDA requirements, delivering:

• Complete Regulatory Writing: Co-Labb provided all necessary written materials for the Pre-IND phase, including the FDA Request Letter, the Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) booklet, and the Pre-IND briefing package. These documents were key to initiating dialogue with the FDA and setting the foundation for BHI’s future regulatory submissions.

  
  

• Expert Regulatory Consultation: Partnering with Dr Angela Johnson, Co-Labb provided BHI with ongoing regulatory advice, helping them navigate the specifics of FDA requirements and ensuring that their clinical trial designs were in line with regulatory expectations.

  
  

• Clinical Trial Design Consultation: We advised BHI on how to structure their clinical trials for FDA approval, ensuring that their study designs would meet the stringent standards for U.S. regulatory approval. This included tailoring their international patient data to comply with FDA guidelines.

  
  

• Regulatory Liaison: Co-Labb will support BHI in key interactions with the FDA, including planned attendance at the Type-B meetings to discuss the clinical development plan and any regulatory concerns directly with the FDA.

By providing both the technical writing and strategic regulatory guidance, Co-Labb ensured that BHI’s Pre-IND application was thorough, accurate, and aligned with FDA requirements, setting the stage for future success.

The Results

Co-Labb’s collaboration with BHI has yielded critical progress toward FDA approval. The high-quality written materials we provided, combined with expert consultation on trial design and regulatory strategy, positioned BHI to confidently move forward in their regulatory journey. Key outcomes include:

• Complete Pre-IND Documentation Ahead of Schedule: Co-Labb delivered all written components of the Pre-IND application, including the FDA Request Letter, INTERACT and Pre-IND booklets, ensuring that BHI’s initial contact with the FDA was comprehensive and well-prepared. Our efficient delivery timeline helped accelerate BHI’s development program.

  
  

• Future Regulatory Support: With planned attendance at the FDA meetingS, Co-Labb will continue to provide real-time support through each stage of the IND application process.

Message from the Co-Labb Co-founder

“It’s been a pleasure working with Blue Horizon International as they pursue FDA approval for their cutting-edge therapies. Our team’s ability to handle both the technical complexities of the IND process and the regulatory nuances has allowed us to offer BHI the full support they need to succeed. We look forward to continuing our partnership and helping BHI bring their life-changing treatments to the U.S. market.”

Dan Sheridan, Co-founder