Tailored Solutions to Meet Your Needs

We provide high-level global strategic input to support the development of regulated products, as well as identify key elements to consider at each stage, including potential hurdles or challenges due to therapeutic area, drug class, or precedent. Our advisory services support projects of any size or scope, whenever you need that support. For clients, we:

• Conduct gap analyses before meeting designated regulatory or development milestones
• Assist with due diligence reviews or asset evaluations by leveraging our extensive research capabilities and experience
• Collect and integrate data to identify creative, strategic solutions to issues or challenges that arise during development
• Support your writing needs across clinical disciplines and disease indications
• Prepare product development plans
• Guide regulatory submission strategy and timing, including in support of generic, hybrid, and “505(b)(2)” development programs
• Conduct and review comprehensive and targeted literature searches
• Leverage our SME status on behalf of clients via our European affiliate

We provide critical insight into region-specific regulations and technical and procedural requirements. Services include:

• Preparation of meeting materials (meeting requests and briefing packages) with FDA and other regulatory authorities
• Representation during regulatory meetings
• Research and review of regulatory precedent
• U.S. Agent or Designated Regulatory Agent support, including maintenance of correspondence logs
• Service on Corporate and Scientific Boards

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. We can provide:

• Guidance on cGMP requirements
• Review and assessment of source documents, such as facility plans, COAs, methods, and master batch records
• Evaluation of the impact of (pre-approval or post-approval) changes and guidance on optimal implementation of changes
• Assessment of comparative physico-chemical properties of complex products, such as biosimilars or liposomal products
• Guidance on botanical drug development
• Management of environmental assessment

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 can:

• Provide guidance on study design for preclinical and DMPK studies and design and/or 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 papers on various technical topics
• Develop strategies for PK/PD modeling and interpretation of data

We offer a full range of clinical development and management support for all Phases (1 through 4) of clinical research, including scientific and medical input, regulatory reporting, and medical writing services. We offer:

• Guidance on study design and preparation and/or review of clinical protocols
• Interpretation of study data and preparation and/or review of clinical study reports
• Preparation of Investigator’s Brochure and drafting and/or review of informed consent documents
• Identification of clinical investigators or Drug Safety Monitoring Board or Steering Committee expert members
• Review of statistical analysis plans and other data management activities
• Safety reporting
• Development and/or review of product labeling
• Other medical writing services

Our experience includes supporting development and marketing efforts for medical devices, in vitro diagnostics, and drug-device combination products. Familiarity with standards, guidelines and industry practices enables our industry experts to provide:

• Guidance on regulatory and business issues involving development, manufacturing, and regulatory challenges
• Insight and advice on marketing applications ranging from 510(k) pre-market authorizations to PMA applications
• Regulatory support in meetings with FDA and other regulatory authorities
• Design and interpretation of Human Factors studies

Our submissions team provides regulatory submission compilation, publishing, and validation services to support electronic submissions to regulatory authorities in eCTD compliant format. Our services include:

• 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 are met and industry best practices are followed. We make the necessary recommendations to ensure successful submissions.
• Submission to authorities: Accounts to the FDA, EMA, and Health Canada are set up and actively maintained for transferring electronic submissions. Proximity of our office 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.
• Non-eCTD formats: We can additionally support non-eCTD formats per each authorities’ specific requirements.