Salamandra, LLC

Salamandra, LLC, is a specialized consulting firm providing strategic, technical and regulatory support for the pharmaceutical and medical device industry. Professional staff includes former FDA medical, toxicology, pharmacology and chemistry reviewers. Our work for the pharmaceutical industry spans all facets of product development, from the early stages of screening and evaluation, to formulation of strategic development plans; and the preparation and production of a wide range of regulatory submissions. Our in-house experts, as well as a wide network of subject matter experts, are prepared to support your company in the areas of chemistry, manufacturing, and controls (CMC), nonclinical and early phase development, and Phase 1-4 clinical development from a regulatory and technical perspective.