“Darmantest Laboratories” LLC

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Darmantest Laboratories (DTL) is a Contract Research Organization (CRO) specializing in Bio-Equivalence, Bio-Availability and Bio-Similar Studies for the pharmaceutical industry.

The company offers beginning to end management including but not limited to:

  • Study Design,
  • Method Development and validation,
  • Protocol Preparation,
  • IRB Submission,
  • Clinical Study,
  • Analytical & Statistical management,
  • Final Study Report.

DTL was established and is managed by American and Armenian professionals whose desire it is to offer high quality service at a reasonable cost. 

Since DTL is in its early stages of growth as a CRO, it is especially important to prove and show potential clients that we are as good as we say we are.  In order to achieve this, we have hired a young, dedicated and motivated staff of; Doctors, PhD’s, Chemists and Pharmacists.  A more accommodating and energetic team you will not find elsewhere.

With its primary client being an American Generic Pharmaceutical Manufacturer, at present, DTL conducts Pilot and Pivotal Studies for single or multi-dose drugs in full compliance with ICH GCP, GLP and GDP and especially U.S. FDA and EMA regulatory guidance.

Adherence to Quality Control is of prime importance to DTL and is conducted by our independent Quality Assurance Department with both, regularly scheduled and impromptu audits, document control, etc.   

DTL’s Clinical Research Center can house up to 65 study subjects, has a self-contained ICU, a large community and dining room, with all the amenities for a comfortable stay for both male and female study subjects. 

The mainstay of the analytical lab is the AB Sciex API 4100 LC/MS/MS.   Additional state-of-the-art equipment includes the Agilent 1290 UHPLC, as well as additional Waters HPLC’s.

Protocols are submitted to a fully independent Institutional Review Board, which is in full compliance with U.S. FDA and EMA regulatory guidelines, to approve and monitor all aspects of DTL’s studies.

DTL maintains its competitive edge by:

  • Continually upgrading our techniques and procedures,
  • Ensuring scientific validity of our work,
  • Creating benchmarks to shape the future of our company,
  • Having a staff that is fluent in English, Armenian, Russian, Farsi, Arabic and French

For additional information see: www.pharmatestlabs.com or contact: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 

MPI Union Members

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Pharma Armenia

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Pharma Magazine

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In April 2015 Medicine Producers and Importers Union of Armenia and “GXP” Centre of Excellence published the 10th issue of pharmaceutical scientific magazine “PHARMA”.

 

www.pharma-mag.am


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