At Salamandra, LLC 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 standards and delivered in a timely fashion.



Our Committed Values

Assurances

We ensure the quality of our products through proper project planning, objectivity, and adherence to scientific and regulatory principles.

Confidentiality

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

Customization

We understand that no project is the same and, as such, all of our work is uniquely tailored to each project’s circumstances and the client’s needs.

Ethics

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

Experience

Our company has been providing consulting to the pharmaceutical industry for over 18 years and our team is filled with staff that have International work and living experience.

Expertise

Our professional staff includes former FDA medical, toxicology, pharmacology and chemistry reviewers. They are supported by an experienced staff of regulatory professionals and technical writers.

Participation

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

Responsiveness

Appropriate flexibility of our work procedures allows us to respond to drastic and immediate changes at any moment's notice.


Quality System

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 Procedues.