Welcome to Salamandra, LLC
Salamandra, LLC provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development.
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 analytical chemistry laboratories.
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. All of our work is return business and by referral, an objective testimonial.
We compete on quality, and aim to set a gold standard with our work products. This means:
Our work 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 such as applications for:
- Investigational New Drugs (IND)
- New Drugs (NDA)
- Abbreviated New Drugs (ANDA)
- Biologics Licenses (BLA)
- Orphan Drug Designations
- Investigational Device Exemptions (IDE)
- Premarket notifications [510(k)]
- Premarket Approvals (PMA)
For European marketing applications, we routinely prepare:
- Investigator Brochures
- Author Pharmaceutical, Pharmaco-Toxicological, and Clinical Expert Reports
- Summary Reports.
- Clinical Trial Applications (CTA)
Associated activities include the development of clinical protocols, case report forms, clinical study reports, labeling, and regulatory submissions to multiple FDA reviewing divisions.
We are fully capable of handling electronic submission formats, including; Structured Product Labeling (SPL), electronic Common Technical Documents (eCTD), and electronic New Drug Applications (eNDA).
Salamandra has a production account with FDA's Electronic Submissions Gateway, and is ready to make submissions through this FDA portal.