About Us
2SD Toxicology Services LLC specializes in providing comprehensive safety assessments for medical devices and diagnostic products. Our core approach is centered around data-driven methodologies, ensuring thorough evaluations, and our reports are built upon rigorous statistical analysis. We strictly adhere to the latest guidelines set forth by regulatory bodies such as the ISO, FDA, and EU-MDR for medical and in-vitro diagnostic devices. Leveraging our extensive expertise in biomedical research, we offer clients the assurance and expert guidance necessary to ensure their products meet the highest safety standards.
To further support our clients, we have expanded our services to include a state-of-the-art laboratory facility. Located in RTP, North Carolina, our facility houses a cutting-edge high-resolution mass spectrometry (HRMS) unit. This enables us to provide chemical characterization studies for medical device manufacturers, assisting them in comprehensively understanding the composition and properties of their products.
At 2SD, we are committed to delivering exceptional toxicology services and facilitating the success of our clients in the medical industry.
Our Consulting Team
Kiran Dhakal, PhD, MPH, DABT
President and Principal Consultant
Dr. Dhakal has over a decade of cumulative experience in the field of toxicology, with a specific focus on ensuring the safety of medical devices and diagnostic products.
Before founding 2SD Toxicology Services, Dr. Dhakal worked as a Consultant Toxicologist at iuvo Bioscience, where he was responsible for biocompatibility assessments of various medical devices, chemical characterization, and toxicological risk assessments of the extractables and leachables of medical devices. He also developed biocompatibility evaluation plans and assessed safety following design and manufacturing changes in medical devices. Prior to that, he worked at LabCorp as a toxicology research scientist for several years, developing bioassays using various bioanalytical platforms.
Dr. Dhakal holds a degree in Veterinary Medicine, a Master's in Public Health in Infectious Diseases from Kansas State University, and a PhD in Toxicology from the University of Iowa. He also worked as a postdoctoral researcher at the University of California, where he focused on the neurotoxicity of organophosphates and developmental toxicity of polychlorinated biphenyls. He is a diplomate of the American Board of Toxicology (ABT) since 2019 and is certified as a clinical/toxicological chemist by the National Registry of Certified Chemists (NRCC) since 2017.