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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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Consulting to the Pharmaceutical Industry

When your pharmaceutical company needs strategic advice, technical writing, regulatory guidance, and more, the professional experts at Salamandra have you covered.

  • Chemistry, Manufacturing, and Controls
  • Nonclinical and Early Phase Development
  • Phase 1-4 Clinical Trials Development
  • Post-Market Surveillance and Safety Monitoring
  • eCTD Publishing and Submissions

Shorten the path to market approval

Salamandra is committed to helping companies optimize their pharmaceutical development process and successfully navigate to market approval.

Product Development

Our work covers all facets of product development, from the early stages of screening and evaluation through preparation of regulatory submissions.

Professional Resources

We have an in-house team of professionals supplemented by a vast network of reliable partners with regulatory and scientific backgrounds.

Industry Experience

Salamandra has accumulated knowledge and expertise from over 20 years of experience supporting the pharmaceutical industry.

International Reach

With offices in both the United States and Europe, Salamandra has undertaken regulatory work or clinical studies in several countries around the globe.

All stages of development

Salamandra effectively supplements client in-house resources throughout the entirety of the drug product development cycle.

Document
Preparation
Preparation of Regulatory and Strategic Documents
CMC
Development
CMC Strategy Development and Implementation Services
Global
Strategy
High-Level Strategic Support for Global Development
Nonclinical
Development
Nonclinical Research and Development Support Including Toxicology and PK/PD
Regulatory
Affairs
U.S. and International Regulatory Affairs Services
Clinical
Development
Development and Management Support for Phase 1-4 Clinical Studies

An Experienced Team

Salamandra’s professional staff includes former FDA medical, toxicology, pharmacology and chemistry reviewers supported by an experienced team of regulatory professionals and technical writers.

Quality Work Product

The internal Quality System at Salamandra ensures work product is of the highest standard, delivered in a timely fashion, and aligns with the current industry standards and best practices.

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