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.

2SD Team

Kiran Dhakal, PhD, MPH, DABT

President and Principal Consultant, Toxicology

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. 

Goverdhan Reddy Vavilala, PhD

President and Principal Consultant, Chemistry

Dr. Vavilala is an experienced Senior Executive with both General Management and Business Development experience in the pharmaceutical/CRO industry. Dr Vavilala has broad knowledge of the drug development process from discovery to clinical research gained through more than 20 years in the CRO/pharmaceutical sector. A strategic thinker and management professional who has gained experience from both small and large companies. Dr. Vavilala is the founder, CEO, of Wake Diagnostics Inc.  a medical and clinical laboratory providing analytical and bioanalytical services. Prior to founding Wake Diagnostics Inc, Dr. Vavilala founded the chemistry based CRO in 2009, HDH Pharma Inc and successfully managed chemistry outsourcing projects with small and large Pharma and Biotech’s. Dr Vavilala has over ten years of medicinal chemistry experience, where he worked on advancing new drug molecules from early lead to lead optimization. He has co-authored over 20 publications, patents, and book chapters. Dr Vavilala received his Ph.D. from IICT, India and was a Post-Doctoral Research Fellow at The Scripps Research Institute in La Jolla, California with Prof. Albert Eschenmoser

Greg Baddick, BS

Director of Business Development

Greg brings over 15 years of extensive experience in the pharmaceutical and diagnostic lab industries. Greg has a proven track record of driving revenue growth, forging strategic partnerships, and launching innovative pharmaceutical, diagnostic and toxicology fields. His leadership has resulted in significant business expansion, including a substantial increase in annual revenue and client base at his most recent position at Wake Diagnostics. Greg's expertise in market analysis, sales strategies, and client acquisition has consistently delivered exceptional results, making him a pivotal force in advancing the company's success. Previously, Greg founded and grew a successful landscape construction firm and held significant roles at Covidien and Bristol-Myers Squibb, where he was recognized nationally for his consistent sales achievements and team development skills. Greg holds a Bachelor of Science in Marketing from Northern Illinois University, where he played Division I Football.

Gautamkumar Patel, PhD

Director of Bioanalytical Services

Dr. Patel has accumulated over 20 years of chemistry experience in the pharmaceutical, environmental, and human exposure research fields. He is currently the Director Bioanalytical Services at 2SD laboratory, where he consults on issues related to toxicology, pharmaceutical and medical device development, regulatory affairs, and human health risk assessment. Bringing his literature research and chemistry background which led to his strong interest in the use of QSAR methods and material chemical characterization for the evaluation of biological risk. Patel has a broad knowledge of Leachable and Extractable testing for both pharmaceuticals and medical devices, from study design through risk assessment. He frequently consults with companies to ensure device biocompatibility evaluation, testing, and risk assessment methods meet current regulatory expectations.