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DITEBA is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries.

We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.

OUR VISION

To be the contract partner of choice for analytical and bioanalytical services.

OUR COMMITMENT TO OUR CUSTOMERS

Diteba will deliver great science and quality excellence, on time, every time.

OUR EXPERTISE

Our science team has extensive knowledge, experience and expertise in analytical and bioanalytical analysis specializing in the ability to resolve the most challenging method development difficulties facing our customers for both large and small molecules.

OUR ACCREDITATIONS

Diteba’s testing services comply with both GLP and GMP and are performed in accordance with the requirements of the US Food and Drug Administration (FDA), Health Canada and the International Conference on Harmonization (ICH). Diteba is licensed by Health Canada as a GMP drug establishment and registered as a drug establishment with the FDA. Diteba is also licensed by Health Canada to handle controlled drugs and substances.

WHAT DO OUR CUSTOMERS THINK?

We are very pleased we contracted Diteba for a wide range of GMP/GLP analytical work for both biomolecules and small molecules in various dosage forms and drug development stages, including Phase 1 to Phase 3 products. The work included method development, validation, drug product release and stability programs. Their staff was supportive, well-informed and experienced with the most up-to-date scientific methods, quality practices and regulatory requirements.”
- Theresa Horne, MSc. – Director, Analytical

We recently engaged Diteba to undertake an IVRT study for a topical spray formulation using the finite dose technique and static Franz Diffusion Cells. Not only did they resolve some very difficult technical obstacles, but they completed the project to our complete satisfaction. I am pleased we chose them to be our IVRT partner.”
- Dr. Chalil Abu-Gnim, Senior Director, Analytical R&D

We had a very positive experience working with Diteba on our Phase 2 oligonucleotide based drug product. The GMP work conducted with Diteba was used to support orphan drug, US and European pre-clinical toxicology, pharmacology, Phase 1 and Phase 2 clinical work as part of an FDA authorized IND and EMA authorized CTAs. That work included analytical methods development, validation, accelerated and long term stability which is still ongoing. We would definitely choose to work with Diteba again on future projects.”
- Dayton T. Reardan, Ph.D., RAC - Vice President of Regulatory Affairs

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We had a very positive experience working with Diteba on our Phase 2 oligonucleotide based drug product. The GMP work conducted with Diteba was used to support orphan drug, US and European pre-clinical toxicology, pharmacology, Phase 1 and Phase 2 clinical work as part of an FDA authorized IND and EMA authorized CTAs. That work included analytical methods development, validation, accelerated and long term stability which is still ongoing. We would definitely choose to work with Diteba again on future projects.
Dayton

6/19/2014

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