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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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Let Our Experience and Expertise Guide the Way

Salamandra is dedicated to its commitment to help clients optimize their pharmaceutical development. From our offices in the United States and Europe, our internal professional team, aided by a network of expert relationships, can help support your needs.

  • Committed to core essential values
  • A reach that extends internationally
  • A diverse team of professionals
  • Access to a vast network of experts
  • An internally developed Quality System
  • Over 20 years of industry experience
Why Salamandra?
  • Core Essential Values
  • International Reach
  • Professional Resources
  • Quality Statement

Committed to core essential values

Salamandra understands the importance of client relationships, that’s why we are committed to upholding core essential values with all our clients.

Assurances

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

Confidentiality

Our technical and human internal systems help ensure proprietary information is rigorously safeguarded.

Ethics

Maintaining the highest ethical standards means we will not accept assignments that conflict with our own ethical beliefs.

Participation

We keep clients actively involved during the entire development of our work product to continuously incorporate their input.

Personalization

We tailor our work to uniquely fit each project’s circumstances, the client’s needs, and industry best practices.

Responsiveness

Appropriate flexibility of our work procedures allows us to promptly respond to drastic and immediate changes.

Our reach extends internationally

Salamandra has experience working with clients based globally, supporting submissions to regulatory authorities in the United States, Europe, and Canada.

International Reach Placeholder
International Reach

A diverse team of scientific and regulatory experts

Salamandra’s professional staff includes former FDA medical, toxicology, pharmacology and chemistry reviewers supported by an experienced staff of regulatory professionals, technical writers, and a vast external network of trusted subject matter experts.

Different and Unique

Led by Drs. Karin A. Kook and Richard Krasnow, our staff members have various levels of education and prior industry involvement;  many have international living and work experience.

Experience Matters

The staff at Salamandra have work backgrounds that include the FDA, regulatory departments in pharmaceutical and medical device companies, as well as toxicology and analytic chemistry laboratories.

Accessible Network

Since the company’s founding in 1996, our highly regarded reputation within the industry has allowed us to steadily expand our access to reputable subject matter experts.

A dedication to quality that is never compromised

Through persistent review and iteration of policies, Salamandra has developed an internal quality system that is thoroughly integrated into our work process and aligns with the current standards and best practices of the pharmaceutical industry.

  • 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.
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22

Years Experience

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1000

eCTD Submissions

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26

Client Represented Countries

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