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Welcome to Salamandra

Salamandra provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development.  Our in-house experts, as well as a wide network of subject matter experts, are prepared to support your company in the areas of chemistry, manufacturing, and controls (CMC), nonclinical and early phase development, and Phase 1-4 clinical development.

Phone: 301-652-6110

Fax: 1-301-652-6739

4800 Hampden Lane, Suite 900, Bethesda, MD 20814

Where to find us

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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.

  • Technical Document Preparation
  • Regulatory Affairs and Strategy Development
  • Chemistry, Manufacturing, and Controls
  • Nonclinical Research and Development
  • Clinical Research and Development
  • eCTD Publishing and Submissions
Our Services
  • Document Preparation
  • Development Strategy
  • Regulatory Affairs
  • CMC Support
  • Nonclinical Support
  • Clinical Support
  • eCTD Services

Preparation of Regulatory and Strategic Documents

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.

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

Strategic Support for Global Development

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.

  • 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

U.S. and International Regulatory Affairs Services

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.

  • 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

Chemistry, Manufacturing, and Controls Services

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.

  • 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

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.

  • 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

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.

  • 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 Publishing and Submission 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.

Electronic File Production

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

Review and Validation

Our submissions team can provide ancillary review support for 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

Accounts to the FDA, EMA, and Health Canada authorities are setup and actively maintained for transferring electronic submissions.  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.

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