Regulatory, Strategic, and Technical Consulting to the Pharmaceutical Industry
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. The focus is on clinical and nonclinical research and development; integration of chemistry, manufacturing, and controls (CMC) information; and eCTD support.
Preparation of Regulatory and Strategic Documents
Our core services include preparation of key technical and regulatory documents to support submissions to FDA, EMA, and Health Canada in CTD compliant format. Our experienced staff helps with preparation of documents that support each module in the CTD format (Modules 1 through 5) for the below applications.
Strategic Support for Global Development
We provide high-level global strategic input on and/or interpretation of relevant regulatory requirements to support the development of regulated products, as well as identify key elements to consider during product development (e.g., potential hurdles or challenges due to therapeutic area, drug class, or precedent). We perform the following activities to support regulatory or development strategies:
Regulatory Affairs Support
Our key areas of regulatory support include the following:
CMC Development Services
Our CMC development services include the following:
Nonclinical Research and Development Services
Our nonclinical research and development services include the following:
Clinical Research and Development Services
Our clinical research and development services include the following:
eCTD Submission Services
Salamandra offers a full range of services that support electronic submissions to the FDA, EMA, and Health Canada regulatory authorities in CTD compliant format, including eCTD format.
Salamandra supports transition of applications from paper to eCTD.