Regulatory, Strategic, & Technical Consulting
Salamandra’s primary products are global strategic development advice and the preparation of key technical and regulatory documents to support submissions to FDA, EMA, and Health Canada in CTD compliant format.
Salamandra’s core services include preparation of key technical and regulatory documents to support submissions to FDA, EMA, and Health Canada in CTD compliant format; our team has experience supporting documents in Modules 1 through 5 of applications.
We provide high-level global strategic input to support the development of regulated products, as well as identify key elements to consider during product development, including potential hurdles or challenges due to therapeutic area, drug class, or precedent.
The knowledge of our regulatory affairs professionals provide critical insight into region-specific regulations and technical and procedural requirements, as well as provide representative support in interactions with regulatory authorities.
Salamandra is an end-to-end solution for drug substance and drug product lifecycle support; our team of CMC experts can help navigate and manage the complexity of CMC strategy development and implementation.
With access to a reliable network of experts in areas of toxicology, pharmacokinetics, and pharmacodynamics, as well as having established relationships with bioanalytical laboratories, Salamandra supports nonclinical research and development needs.
We offer a full range of clinical study development and management support for all Phases (1-4) of clinical research, including data management, drug safety reporting, and medical writing services.
Our submissions team provides regulatory submission compilation, publishing, and validation services to support electronic submissions to the FDA, EMA, and Health Canada regulatory authorities in eCTD compliant format.