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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.

  • 301-652-6110
  • 1-301-652-6110
  • 4800 Hampden Lane, Suite 900
    Bethesda, MD 20814-2998

Our Location

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Phone: 301-652-6110 Fax: 1-301-652-6739

Expect Work Product of the Highest Quality

At Salamandra our commitment is to help clients optimize their pharmaceutical development, thus shortening the path to regulatory approval. We also commit to the appropriate application of regulatory standards and industry best practices. Our team is dedicated to meeting these promises by following the policies of a Quality System that ensures work product is of the highest standard and delivered in a timely fashion.

A quality system that continually adapts and improves.

Salamandra’s Quality System is derived from a tried and tested process that incorporates consistent review and iteration of policies.  This ensures that quality control is thoroughly integrated into our work process and aligns with the current standards of the pharmaceutical industry.

Salamandra's dedication to quality is absolute and never compromised.
  • The Foundation
  • Procedure Development
  • Regulatory Intelligence
  • Process Evaluation

The 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.

Procedure Development

  • Staff continuously train and document records of such training.
  • Staff are exposed to all aspects of our work to promote knowledge and familiarity of procedures.
  • 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.
  • An internal database of official guidance and procedural documents is maintained.
  • Our Standard Operating Procedures are swiftly modified to match any regulatory standard changes.

Process Evaluation

  • We undertake continual improvements of our standard operating systems and Information Technology platforms.
  • Internal systems of logging and tracking allow for end of project reviews.
  • All staff are encouraged to raise concerns over Standard Operating Procedures.

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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