Increasingly, a product developed outwith 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/manufacture is to take a step back and to ‘see the wood for the trees’ or in other words taking the time to gain an objective, aerial view of the regulatory interface where the 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 stream-lining where required and confirming compliance where found.
VBS can also help with mature systems by supplying an 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
  • 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.

• Product Development Strategic Support
• Regulatory Support
• Contract Qualified Person Services
• Quality Systems Review, Integration and Upgrades
• Customised Training
• Plant Design, Validation, PPM and Other Engineering Solutions