Boots Analytical Services provide a tailored package for all or part of your regulatory requirements with:

• Large ICH compliant storage chambers configured at the following environmental conditions:
  
  • 5ºC
  • 25ºC/60% RH
  • 30ºC/65% RH
  • 30ºC/75% RH
  • 40ºC/75% RH
  • 25ºC photostability cabinet

  These cabinets are continuously controlled and monitored by an external bureau using the BAS 2800+ system. This system measures, records and logs all temperature and humidity readings in the chambers.

• Protocol design preparation and trial management using a fully validated Laboratory Information Management System (LIMS)
• Generation of all documentation for licence submissions. (This will be compiled in accordance with customer requirements)

Documentation design and preparation

We offer a full report writing service. This bespoke service is offered where clients’ needs are closely matched to industry documentation conventions.

• Generation of all documentation for license submissions
• Stability reports compiled in accordance with CPMP-ICH preferred format which leads to ready incorporation into dossier submissions
• Compilation stability testing protocols, validation protocols
• Validation reports
• Technology transfer reports
• Certificates of Analysis
• Non- routine documentation in support of the
  product development process