Salamandra, LLC provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development. We have been building a reputation for quality and expanding our range of services since the company’s founding in 1996. Our client base and project portfolio have steadily increased since then, as has our International reach.

Meet Our Team

Our professional staff includes former FDA medical, toxicology, pharmacology and chemistry reviewers. They are supported by an experienced staff of regulatory professionals and technical writers with work backgrounds that include regulatory departments in pharmaceutical and medical device companies, as well as toxicology and analytic chemistry laboratories.

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What We Do

Our primary products are strategic development advice and the original writing of technical submission documents. The focus is on clinical and nonclinical development; integration of chemistry, manufacturing, and controls (CMC) information; and regulatory support. While our efforts are mainly directed at regulatory agencies in the United States and overseas, informing investor audiences is also a frequent objective.

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International Reach

Besides the United States, we also maintain a presence in Europe where work is carried out either at the office of our affiliate in Paris or in our office in Milan, Italy. We have also undertaken regulatory work or clinical studies in several other countries around the globe. Our professional staff has various International living and work experience. For non-U.S. companies, we often are the named U.S. Agent and therefore the primary regulatory point of contact.

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