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Excelsus Consortium

Excelsus Consortium presently consists of two entities, although it is conceived to eventually welcome other companies sharing the same Excelsus' values:

 

Excelsus Scientific Engineering (ESE) founded in April 2001 by Dr Arturo Araque, which offers scientific services to (bio)pharmaceutical companies in the field of validation of manufacturing processes.

 

Excelsus Structural Solutions (ESS) founded in March 2012 by Dr Fabia Gozzo, which offers advanced analytical services based on synchrotron-X-Ray Powder Diffraction to the pharmaceutical, food and chemical industry.

The objective of Excelsus Consortium is to combine advanced analytical services with experienced GMP consulting and offer them to the (bio)pharmaceutical industry throughout the whole life-cycle of products as performed by highly qualified professionals in engineering and scientific areas who are used to handle proprietary information with high confidentiality standards.

 

With extensive experience in process validation (ESE) and product characterization (ESS), Excelsus Consortium is particularly best positioned to provide integrated solutions to help its customers meet the new regulatory guidance on these topics (ICH Quality guidelines).

 

Services include in particular:

 

 1. GMP Consulting in the fields of:

 

  • Qualification of equipment, utilities and lab instrumentation
  • Validation of manufacturing processes, including parameter criticality assessment, determination of validation strategy, development and justification of acceptance criteria
  • Cleaning and methods validation
  • Computer system validation
  • Generation or revision of the Validation Master Plan.

 

More under Excelsus Scientific Engineering (ESE)

2. Synchrotron-X-Ray Powder Diffraction Characterization for qualitative and quantitative analysis of organic structures with privileged access to state-of-the-art Synchrotron-based techniques that allow:

  • an enhanced selection
  • precise identification
  • quality-by-design development
  • highest attainable purity in the manufacturing of biotech, pharmaceutical, chemical and food products.

 

More under Excelsus Structural Solutions (ESS)

 
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