Dromex International

We Empower Your Pharmaceutical
Business

With over 15 years of experience in the global pharmaceutical industry Dromex International has been representing the world's most respected manufacturers of pharmaceutical ingredients and finished products.

Our laboratory

Dromex Innova

Integral solutions for the development of pharmaceutical products.

We are a Galenic and Analytic Development Laboratory that provides integral solutions for the development of new pharmaceutical and biological/biotechnological products, following the process from the selection of API to the scaling-up in the production plant and registry.

We offer pharmaceutical R&D and analytical R&D services, quality control services and stability studies, development and optimization of lyophilization cycles, lyophilization of pilot batches, technology transfer and training services, dossiers in CTD format and advice in regulative matters.

In Dromex Innova we are specialized on satisfying the needs of our clients, planning and integrating the different stages of each development project to provide them a solution that suits their demands.

For this reason, we rely on a highly qualified professional team with pharmacists, biochemists, biotechnologists, biologists, chemists, engineers, technical support staff, and with the state-of-the-art technology equipment.

We believe that the only way to work to obtain optimal results and ensure the success of the projects is through a interdisciplinary teamwork involving different areas and specialties.

In Dromex Innova we are fully committed to excellence and quality work.

Institutional Video

Pharmaceutical R&D Services

Development of pharmaceutical similar and biosimilar formulations:

  • - Preformulation studies..
  • - Formulation development

Scaling-up and optimization of the fabrication processes.

Production of pilot batches.

We work with every pharmaceutical form:

  • - Coated and uncoated tablets, dispersible tablets, immediate-release and extended-release dosages.
  • - Gels, creams, ointments.
  • - Syrups.
  • - Sterile liquids and powders: solutions, suspensions and lyophilizates.

The Plant

Galenic Laboratory

Analytical R&D Services

Development of analytical methods for a large spectrum of pharmaceutical and biopharmaceutical forms:

  • - Identification tests.
  • - Assays.
  • - Purity tests.
  • - Profiles and dissolution tests.
  • - General tests: moisture content, pH, others.

Validation of analytical methods:

  • - Validation of analytical methods according with the international guides and pharmacopoeias.
  • - Verification of compendial methods.
  • - Revalidation.

The Plant

Analytic Laboratory

Quality Control and Stability studies

Quality control of pilot batches

Quality control of productive batches.

Stability studies at controlled temperature and humidity of pilot batches.

  • - Short term, accelerated.
  • - Long term.
  • - In all climatic zones according to ICH guidelines.

Lyophilization Service

We develop lyophilization cycles from scratch or optimize existing cycles to produce a stable product

We focus on the optimization of the following parameters:

  • - Low residual moisture.
  • - Cake appearance.
  • - Reconstitution.
  • - Total run time.

We have a pilot scale lyophilizer that allows us to lyophilize pilot batches in vials and bottles of various volumes.

Technology Transfer and Training

Establishing and management of the Transference Plan.

Support on key transfer parameters for all types of products, including biotechnological.

Training on production and quality control methods both in our facilities as well as at the client’s facilities.

Regulatory affairs

Advice on regulatory strategies for pharmaceutical products registration in the country of interest.

Support services to the regulatory departments of pharmaceutical companies with documentation for registration and response to requests from the local sanitary authority.

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Documentation review service and assembly of Expert Report

Dossiers

Dossier in CDT/eCTD format or in the format requested by the local sanitary authority.

Offices
ARGENTINA: DRX INTERNATIONAL S.A.
Av. Escalada 1454
C1407LED - Buenos Aires - Argentina +54 11 46703450 +54 11 46703454
SPAIN: DRX INTERNATIONAL S.L.
Agricultura 16-18, 2do piso, oficina 2.3
08320 El Masnou - Barcelona - España + 34 935556785
e-MAIL
DRX International: info@dromexint.com
Contact