About Us

At 2SD Toxicology Services LLC, we specialize in delivering data-driven safety assessments for medical devices and diagnostic products. Our approach ensures thorough evaluations, backed by rigorous statistical analysis and adherence to the latest regulatory standards, including ISO, FDA, and EU-MDR guidelines.

State-of-the-Art Laboratory & Chemical Characterization Services

To further support our clients, we have expanded our capabilities with a state-of-the-art laboratory facility in RTP, North Carolina. Equipped with high-resolution mass spectrometry (HRMS), we offer chemical characterization studies that help medical device manufacturers gain a deeper understanding of their products' composition and properties.

Partner with us to ensure the safety, quality, and success of your products.

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.

Dr. Dhakal has extensive experience working with CROs, including iuvo Bioscience, LabCorp, and Quality Laboratory Services. He brings deep expertise in medical device biocompatibility evaluation, extractables and leachables studies, and toxicological risk assessment.

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. 

Robert D. Voyksner, PhD

Senior Consultant, Analytical Chemistry

Dr. Voyksner serves as an Adjunct Professor at both the North Carolina State University College of Veterinary Medicine and the University of North Carolina Eshelman School of Pharmacy, where he teaches courses and mentors student research in mass spectrometry.

His research in analytical chemistry, with a focus on mass spectrometry, has led to 100 peer-reviewed publications and over 250 scientific presentations at conferences. He has been a member of the Board of Directors for the American Society for Mass Spectrometry (ASMS) and serves on the organizing committee for the Montreux LC/MS Symposium. Additionally, he organized the Montreux LC/MS Symposia in 1995, 1999, 2003, 2007, and 2014. Over the past 30 years, Dr. Voyksner has taught more than 156 courses on analytical mass spectrometry.

Raya Martinez, BS

Biocompatibility Consultant

Raya Martinez is a biomedical engineer and project manager specializing in biocompatibility, regulatory compliance, and risk assessment for medical devices. With expertise in Lean Six Sigma and process development, she continuously improves processes efficiency and ensures regulatory readiness.

Raya has experience in quality control, technical and scientific report generation, and biomaterials engineering, supporting toxicological risk assessments and regulatory submissions. She holds an M.S. in Technology Management with a concentration in Lean Six Sigma from North Carolina A&T State University and a B.S. in Biomedical and Health Sciences Engineering from the Joint BME Department at UNC-Chapel Hill and NC State University. Raya is also certified as a Lean Six Sigma Green Belt and holds the Google Project Management Professional Certification.

As a biocompatibility consultant, Raya helps companies navigate regulatory requirements by leveraging her expertise in data analytics and statistical modeling to assess product safety and compliance. She works closely with clients, providing consulting services, regulatory guidance, and technical documentation support.

Goverdhan Reddy Vavilala, PhD

 Principal Consultant, Organic Chemistry and drug development

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

Scientist, Bioanalytical Services

Dr. Patel has over 20 years of experience in chemistry, spanning the pharmaceutical, environmental, and human exposure research fields. He has extensive hands-on expertise in operating and maintaining HPLC, LC/MS, and GC/MS instruments. Throughout his career, he has successfully led multiple pharmaceutical projects, including extractables and leachables (E/L) studies, impurity detection, stability assessments, and chemical identification.