De-risking development of genetic medicines through integrated scientific and regulatory leadership with a focus on rare diseases and advanced therapies

Franklin Biolabs, a fully integrated preclinical contract research organization (CRO) at the forefront of genetic medicine and biologics innovation, and RareMoon Consulting, a regulatory services organization focused on orphan drugs and advanced therapies, today announced a strategic partnership to offer joint consulting packages supporting preclinical‑to‑clinical transitions.

This collaboration creates a seamless path from early development through clinical submission, enabling sponsors to advance nonclinical and manufacturing programs through a directed, regulatory‑aligned approach. By designing and implementing development plans focused on meeting regulatory expectations and avoiding unnecessary studies or data that do not meaningfully advance the program, the partnership helps reduce development risk, prevent delays, and accelerate timelines for the clinic and patients in need of life-changing therapies.

"At Franklin Biolabs, we are committed to providing our clients with the comprehensive expertise needed to advance IND and BLA submissions and approvals," said Dr. Vatsala Naageshwaran, Chief Executive Officer of Franklin Biolabs. "By aligning closely with RareMoon's regulatory leadership, we strengthen our ability to design nonclinical programs that are both scientifically rigorous and directly aligned with regulatory expectations. This partnership enhances our end‑to‑end capabilities, accelerates development timelines, and reinforces our role as a trusted partner in bringing transformative cell and gene therapies to patients worldwide."

Sabrina Mogle, Co‑Founder and Chief Executive Officer of RareMoon Consulting, added, "This strategic alignment with Franklin Biolabs creates a powerful opportunity for our gene therapy and rare disease clients to move from planning to execution in an intentional and focused way. Together, we help sponsors design and implement development programs that prioritize what regulators minimally require, while avoiding unnecessary studies and data that add time, cost, and complexity without advancing the program. This collaboration strengthens our shared commitment to efficient, regulatory‑ready development and program execution, as we continue to serve as trusted partners across every stage of the development journey."