Quality Systems, Training and Engineering Solutions

Increasingly, a product developed without an appropriate Quality Management System stands little chance of success either at partnering or licensing stages. Very often the most difficult thing when focussed on product development and manufacture is the capacity to step back and see the bigger picture, taking the time to gain an objective, aerial view of the regulatory interface where science meets the compliance. The company must understand what is really going on, so that a fully integrated, effective quality system can be implemented and managed to meet the needs of the business. Vyvo Biosolutions can perform an independent review of your current Quality Management Systems with a view to upgrading or streamlining where required and confirming compliance where found. Vyvo Biosolutions can also help with mature systems by supplying interim support in cases of peak work load.

The following are some of the services we provide in this area:

  • GMP compliance gap analyses, design and implementation of upgrades to quality systems
  • Mock Pre-Approval Inspections
  • Assistance with regulatory inspection remedial action planning
  • Plant design, validation, PPM and other engineering solutions
  • Supplier audit and contractor selection and management
  • Advice and assistance with manufacturing process and analytical method validation
  • Customised GMP and Regulatory training