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  Case Studies

Responsiveness Saves Manufacturer Millions
  A major pharmaceutical company was threatened with a facility shut down by the FDA due to the presence of unknown particles in one of their processes. A lengthy shutdown would cost the company millions of dollars.
 
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Phone: 1-206-357-5997
Fax 1-206-299-9878


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info@itg-labs.com

 
Case Studies

 

Case Study 1

Our team arrived on site within 24 hours and discovered that some on the chemicals used for the manufacturing process was contaminated. Since we were able to pin-point the source of contamination the company was able to locate other suppliers for the chemical.

• We analysed problem in depth
• Prepared validation protocols for improved tests
• Provided support in execution of validation protocols
• Prepared validation report

Case Study 2:

We were asked to provide support to a research-based
drug discovery company.

• Design of a pharmaceutical compound selection process
• Salt and morphic form selection
• Development of pre-clinical formulations for toxicology testing
• Preformulation studies as part of compound selection
• Design and development of materials for 'First in Man' studies
• Selection and supervision of the manufacturer of clinical materials
• Development of the manufacturing elements of the Investigational Medicinal    Product regulatory dossier
• Supervision of the clinical trial packaging operation on the behalf of
   the sponsor

Our contribution enabled company to move forwards cost-effectively and quickly, saving substantial amounts of time and money.

Our unique expertise opened up new possibilities and ideas to our client, increasing their chance of a successful product development.


 
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