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.

INDs

NDAs

ANDAs

BLAs

MAAs

CTAs

Our regulatory, strategic, and technical services effectively supplement client in-house resources throughout the entirety of the drug product development cycle, from nonclinical and early phase development through Phase 1-4 clinical trials development.

Support for all stages of product development.

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.

Investigational New Drug Applications (INDs)
New Drug Applications (NDAs)
Abbreviated New Drug Applications (ANDAs)
Biologic License Applications (BLAs)
Marketing Authorization Applications
Clinical Trial 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:

Conduct gap analyses prior to meeting designated regulatory or development milestones.
Assist with due diligence reviews.
Collect and integrate data to identify creative strategic solutions to issues or challenges that arise during drug development.
Prepare product development plans.
Provide guidance on regulatory submission strategy and timing.
Conduct and review comprehensive and targeted literature searches.

Regulatory Affairs Support

Our key areas of regulatory support include the following:

Preparation of meeting materials (meeting requests and briefing packages) with FDA and other regulatory authorities.
Representation at regulatory meetings.
Research and review of regulatory precedent and labeling.
US Agent or Designated Regulatory Agent support, including maintenance of correspondence logs.

CMC Development Services

Our CMC development services include the following:

Provide guidance on cGMP requirements.
Review and assessment of source documents, such as facility plans, COAs, methods, and master batch records.
Evaluate impact of (pre-approval or post-approval) changes and provide guidance for optimal implementation of changes.
Assess comparative physico-chemical properties of complex products, such as biosimilars or liposomal products.
Manage environmental assessment programs.

Nonclinical Research and Development Services

Our nonclinical research and development services include the following:

Provide guidance on study design for nonclinical and DMPK studies and review protocols.
Interpret study data and review study reports for accuracy and completeness.
Assess, oversee, and manage nonclinical contract laboratory organizations (CROs) and bioanalytical laboratories.
Prepare detailed scientific white paper on various technical topics.
Develop strategies for PK/PD modeling and interpretation of data.

Clinical Research and Development Services

Our clinical research and development services include the following:

Provide guidance on study design and prepare and/or review of clinical protocols.
Interpret study data and prepare and/or review clinical study reports.
Prepare Investigator’s Brochure and review ICF.
Provide support for clinical trials, including identifying investigators, reviewing statistical analysis plans and other data management activities, and safety reporting.
Develop and/or review product labeling.
Other medical writing services.

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.

Electronic File Production

We produce submission ready electronic files with fully compliant formatting, linking, and bookmarking. We ensure our electronic production passes all current technical validation criteria.

Review and Validation

We can work with companies to review compiled eCTD submissions to ensure validation criteria is met and industry best practices are followed. We make recommendations that lead to successful submissions.

Submission to Authorities

We maintain active accounts for transferring electronic submissions to the FDA, EMA, and Health Canada. Our close proximity to the FDA receiving office allows us to conveniently provide electronic submissions on physical media in emergency situations.

Technical Support

The underlying technical aspects that make up the eCTD standard are often confusing to those without training or industry experience. Our submissions team has the knowledge to assist with any eCTD related technical issues that may be encountered.

Salamandra supports transition of applications from paper to eCTD.

Interested in learning more about us?

If you would like more information about Salamandra please contact us today and someone will get back to you shortly.

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