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Let our experience and expertise guide the way

At Salamandra, we have an in-house team of experts with more than three decades of experience in the pharmaceutical industry, offices in the United States and Europe, as well as a reliable network of partners with regulatory, medical, and scientific backgrounds. 

We leverage the integrity, capabilities, and stability of our staff and network to provide superior strategic, technical, and regulatory assistance to clients engaged in pharmaceutical and medical device development. Our tailored solutions and focus on quality are enhanced by our “big picture” multidisciplinary approach. 

  • 26+ years in business
  • 2000+ eCTD submissions
  • 28 client-represented countries

Committed to core essential values

Salamandra understands the importance of client relationships – that is why we are committed to upholding our core essential values with all our clients. Besides positive interactions with regulatory authorities, we also measure our success by requests for repeat business and referrals from current or former clients.

  • Assurances

    Proper planning, objectivity, and adherence to scientific and regulatory principles ensure the quality of our work.
  • Ethics

    Maintaining the highest ethical standards means our work practices are always based on the principles of integrity, honesty, and respect.
  • Personalization

    Our services are tailored to uniquely address each project’s specific needs and circumstances, while incorporating industry best practices.
  • Participation

    We keep the client actively involved during all aspects of our work, continuously incorporating their input and working collaboratively throughout project development and delivery.
  • Responsiveness

    Appropriate flexibility of our work procedures allows us to promptly respond to critical client needs.
  • Confidentiality

    Our scientific and operational policies and procedures help ensure proprietary information is rigorously safeguarded.

A dedication to quality that is never compromised

  • Quality Foundation

    • We cultivate the idea that quality at all levels has a direct impact on our ability to meet client expectations.
    • Management not only promotes but takes an active role in our quality system.
    • All of our final work products are required to pass through appropriate quality controls.
  • Continuous Development

    • Staff continuously train and document records of such training.
    • Staff are exposed to all aspects of our work to promote and expand knowledge and familiarity with procedures, scientific principles, and to have a “big picture” view of their work.
    • Through this cross-training, our clients effectively gain access to the experience and talent of all staff members.
  • Regulatory Intelligence

    • All work is evaluated using current regulatory thinking.
    • Our internal procedures include the rigorous monitoring, gathering, analyzing, and sharing of new and updated regulatory information. 
    • Pertinent new and updated regulatory information is communicated in a timely manner to clients.
  • Process Improvement

    • We undertake the continual improvement of our standard operating systems and Information Technology platforms.
    • Quality systems are regularly internally audited to ensure maintenance of the highest performance standards. 
    • All staff are encouraged to raise any concerns over Standard Operating Procedures and suggest improvements.

Our reach extends globally

Salamandra has experience working with clients internationally, supporting submissions to regulatory agencies in the United States, Europe, Canada, and China, amongst others.

Expert resources

Salamandra’s professional staff includes former FDA medical, pharmacology, and chemistry reviewers supported by an experienced staff of regulatory professionals, physicians, technical writers, and an extensive external network of trusted subject matter experts. We have backgrounds that include:

  • FDA
  • Regulatory and R&D in pharmaceutical, biotechnology and medical device companies
  • Experience in toxicology and analytical chemistry laboratories

Our experience matters.

The professional experts at Salamandra are here for you

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