Who we are

Salamandra, LLC provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development. Professional staff includes former FDA chemistry, toxicology, medical, and post-marketing safety reviewers. Our primary products are strategic development advice and original writing of the 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.

Work for client firms has spanned 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. For drugs and biologics, these include Investigational New Drug applications (IND), New Drug Applications (NDA) including in Common Technical Document (CTD) format, Abbreviated New Drug Applications (ANDA), Biologics License Applications (BLA), electronic Structured Product Labels (SPL), their various amendments, as well as applications for Orphan Drug Designation. For devices, these include preparation of the Investigational Device Exemption (IDE), premarket notification [510(k)], and Premarket Approval (PMA) applications. For non-U.S. companies, we often are the named U.S. Agent and therefore the primary regulatory point of contact.

For U.S. and European marketing applications, we routinely prepare Investigator Brochures and author the Overview sections (comparable to the former Pharmaceutical, Pharmaco-Toxicological, and Clinical Expert Reports) and the accompanying Summary documents. European work is carried out either at the office of our affiliate in Paris or in our office in Milan, Italy. Besides the United States and Europe, we have also undertaken regulatory work or clinical studies in several other countries around the globe.

Alongside the development of major regulatory documents, Salamandra, LLC offers support for a broad range of associated activities. In the clinical arena, we regularly develop protocols, case report forms, clinical study reports, and regulatory submissions to multiple FDA reviewing divisions. We also undertake related tasks such as identification of investigators and contract laboratories, review and management of statistical analysis, preparation for and representation at FDA and advisory committee meetings, as well as implementation of data safety monitoring boards. In addition, we provide ancillary support services including implementation and management of adverse event reporting systems; literature searching and database management; and production of regulatory submissions in both paper and electronic form, including the assembly, proofreading, delivery, and maintenance of regulatory files. Finally, as companies grow, we assist in the development of in-house capabilities in all of these areas through tailored in-house training.

We have a record of exceptional client satisfaction in all of these areas. All of our work is by referral or repeat business, as we do not advertise. Every aspect of our clients’ projects is kept under strict confidentiality.