Salamandra, LLC is committed to helping companies navigate the pharmaceutical development process.
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 Work Product
Investigational New Drug Applications
New Drug Applications
Abbreviated New Drug Applications
Biologic License Applications
Investigational Device Exemptions
Investigator Brochures and Summary Reports
Our work product meets electronic common technical document (eCTD) validation guidelines.
We support submissions through FDA's Electronic Submissions Gateway.
Associated services include the development of clinical protocols, case report forms, clinical study reports, labeling, 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.