QUALITY ASSURANCE

Doctor Checking a Form

Putting the Good back into GxP

Services

An essential part of any regulatory undertaking is to ensure your internal systems, or those of your supplier or client meet the necessary requirements. Following good practice (GxP) guidelines is non-negotiable to make sure all aspects of the regulator’s standards are met.

 

At Vicore, we have a broad spectrum of GxP competencies in quality management as well as in adjoining regulatory areas. This approach allows us to provide additional value especially for organisations without a dedicated quality management team that focuses on GxP.

We offer advice, guidance and solutions in the following areas:

  • Providing consultancy, gap analyses and operative support on GxP topics

  • Designing, implementing and improving your GxP quality system

  • Preparing licence applications for manufacturing and wholesaling authorisations

  • Designing and documenting processes as SOPs

  • Improving your risk management approaches

  • Supporting and assisting in preparation for health agency inspections

  • Supporting remediation activities

  • Providing Responsible Pharmacist/ Deputy RP solutions as a locum service