Salamandra, LLC Email Format
Professional ServicesMaryland, United States11-50 Employees
Salamandra, LLC operates as a specialized consulting firm that provides strategic, technical, and regulatory support to the pharmaceutical and medical device sectors. Its team includes professionals who have served as FDA reviewers in medical, toxicology, pharmacology, and chemistry. The firm covers the full spectrum of product development, from early screening and evaluation to formulating development strategies and assembling regulatory submissions. Beyond its in-house experts, Salamandra maintains a broad network of subject matter specialists to assist with chemistry, manufacturing, and controls, nonclinical and early-phase development, and Phase 1-4 clinical development from regulatory and technical perspectives. Based in Bethesda, Maryland, the company serves pharmaceutical and medical device developers seeking regulatory and technical guidance across development stages. A 2019 news item indicates that Penguin Random House Group acquired Salamandra, LLC in May of that year.