As the current financial year draws to a close, we are pleased to report that Palamur Biosciences could successfully maintain its focus on its primary objectives despite various challenges and hurdles. Looking ahead to the 2025-26 fiscal year, we plan to continue this approach with a stronger emphasis on pharmaceuticals and large animals segments with particular reference to non-human primates,. Our goal is to be your research partner of choice, providing reliable, innovative, and compliant solutions to advance your programs.
We also take this opportunity to thank you for your continued support and trust in Palamur Biosciences (Palamur) during the current year. We are optimistic that 2025-26 will bring new opportunities to serve you even better.
As part of our commitment to transparency, we are pleased to share an update on the recent U.S. FDA BIMO investigation conducted at our test facility:
- Over the course of a six-day audit by a team of seven investigators, we believe our staff performed admirably throughout the process and have accounted themselves well.
- While there were a few observations, primarily related to the refinement of raw data reconstruction under 21 CFR Part 58.3(k), the inspection affirmed that our GLP activities align with industry standards, with no impact on Palamur’s NGCMA GLP certificate.
- We submitted a comprehensive response to the FDA on February 17, 2025, addressing all observations with detailed Root Cause Analysis, CAPA, and verification measures. We believe this submission will be adequate for the FDA to close the investigation and provide a positive outcome.
- Overall, this inspection has been a valuable learning experience, giving us the opportunity to further refine our processes, like our earlier NGCMA audits conducted at the behest of the US EPA.
- We also thank our US FDA GLP expert, Ms. Barbara Munch, our mentor, and Dr. Stanley, the Indian OECD GLP expert, for their invaluable contributions in continuously helping us with the GLP processes and educating us to do what is right.
We are committed to fortifying our systems and procedures at our test facility to build proper data collection and reporting processes, enabling sponsors to make appropriate safety assessments to protect patients using such data. One of our major initiatives is investing in technology and software support, as well as fostering a culture of quality excellence. We aim to make quality systems an integral part of our operations.. As the Greek philosopher Aristotle wisely said, “Excellence is an art won by training and habituation; therefore, excellence is not an act but a habit.” In the upcoming fiscal year, our objective is to perpetuate this art of excellence.
We are installing online data capture software, Xybian Prestima, to improve our data capturing processes, which we believe will be online during the second quarter of the next financial year. Additionally, we are making various changes in SOP processes, including creating a separate Animal Welfare and Ethology Department to specifically focus on the well-being of our various test systems.
Additionally, we aim to share our key learnings and experiences from the US FDA and US EPA audits through comprehensive root cause analyses. We plan to disseminate these insights via a series of blogs to benefit the scientific community and invite feedback for further refinement and improvement. Many of the discussed points originate from training sessions led by the US FDA GLP expert, to whom we extend our gratitude for her mentorship and guidance.
We will post these blogs weekly, covering various topics that we believe will add significant value to the scientific fraternity.
Thank you once again for your unwavering support. We look forward to a successful and productive year ahead
Dr. Ramamamoorthy
CEO and Test Facility Management
Palamur Biosciences (P) Ltd ( Palamur)
