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Corporate Capabilities Presentation www.diteba.com
Who We Are ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What We Offer ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What We Offer ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What We Offer ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What We Offer ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Our Organization
Management and Key Personnel ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Management and Key Personnel
Management and Key Personnel ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory History DATE REGULATORY AGENCY CATEGORY RATING/Status Sep 2005 Health Canada Pharmaceuticals C  (Compliant) July 2006 Health Canada Control Drugs and Substances Status: licensed Feb 2008 Health Canada Biologicals; Pharmaceuticals C  (Compliant) Feb 2009 Health Canada  Class A Precursors Status: licensed Mar 2010 Health Canada  Biologicals; Pharmaceuticals C  (Compliant)
Analytical R&D Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
QC Release Testing Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Physical Testing Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Bioanalytical Testing Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Bioanalytical Testing Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Formulation Development Testing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Stability Testing Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Stability Storage Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution and In Vitro Release Testing ,[object Object],[object Object],[object Object],[object Object],[object Object]
Semisolids In Vitro Release Testing ,[object Object],[object Object],[object Object],[object Object],[object Object]
Semisolids In Vitro Release Testing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Key Equipment
State-of-the-Art Laboratory Infrastructure ,[object Object],HPLC, UPLC, UPLC/MS GC  EMPOWER Database ELN- TBD SDMS: NuGenesis Database UV, TOC, FTIR, AA, ELISA & Other applications  without Database NuGenesis can also capture files from various applications that do not have their own database  Final document for submission to client by Web access (in development) or in paper format. Balances & pH meter MS Office applications Temperature and Humidity Monitoring system for Stability Chambers by Rees Scientific
Key Partnership: Thesis Chemistry ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Key Partnership: Thesis Chemistry ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Our Experience Methods Developed in the Last 36 Months
Our Experience Recent Analytical Projects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Our Experience Recent Analytical Projects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Our Experience Recent Bioanalytical Projects ,[object Object],[object Object],[object Object],[object Object],[object Object]
Our Experience Recent In Vitro Release Testing Projects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Thank you!

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Diteba's Corporate Capabilities for Pharmaceutical R&D Services

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  • 11. Regulatory History DATE REGULATORY AGENCY CATEGORY RATING/Status Sep 2005 Health Canada Pharmaceuticals C (Compliant) July 2006 Health Canada Control Drugs and Substances Status: licensed Feb 2008 Health Canada Biologicals; Pharmaceuticals C (Compliant) Feb 2009 Health Canada Class A Precursors Status: licensed Mar 2010 Health Canada Biologicals; Pharmaceuticals C (Compliant)
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  • 27. Our Experience Methods Developed in the Last 36 Months
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Notas del editor

  1. Diteba has a dedicated Stability and Analysis group providing services for all stages of drug development, from early research & development to commercial/post approval studies, in full compliance with ICH, Health Canada, EMEA and FDA requirements. Our Stability department is integrated within the laboratory complex and provides the following services for all storage conditions. Every chamber is electronically monitored and on automated generator back-up.