Quality Assurance

Quality Assurance is an essential aspect of your business. White-Salters Consulting can assist you as you develop your Quality Management System, develop it for you, or provide resource support to ensure functional tasks are completed. Our talented team has the skill and industry expertise to provide the level of support that is fit for the purpose.

A few of the services we routinely provide include:

  • SOP Development
  • GLP, GCP, GMP, and GVP Vendor Auditing
  • Gap Analysis
  • Pre-Approval Inspection Assistance
  • Documentation Review (Batch Records, Stability Data, Packaging Record, etc.)
  • Pre-clinical Protocol and Final Report Review
  • Clinical Documentation Review (Protocols, CSRs, IBs, SOCs, etc.)
  • Regulatory Submission QC
  • Qualified Person Services

Our team of experts can work with you to address all the Quality Assurance needs of your organization.

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Regulatory Affairs

White-Salters Consulting (WSC) understands the vital importance of Regulatory Affairs for companies that produce pharmaceuticals, biotechnology products, and medical devices. Each business seeking to gain or maintain market authorization must create a reliable regulatory strategy that governs drug development, manufacturing procedures, clinical research, and marketing practices. WSC consults with businesses to develop or assess their Regulatory Affairs process to ensure it supports compliance at all levels and is equipped to deal with changing laws and regulations associated with Regulatory Affairs.

The consultants at WSC have spent years working in the industry and honing their expertise in all areas of Regulatory Affairs. Give us a call to discuss the comprehensive list of services available to allow your company to operate in complete regulatory compliance.

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GXP Training

At White-Salters Consulting, we recognize that keeping staff appropriately trained and up-to-date with regulations at all times is challenging, especially when industry guidelines are evolving and changing constantly. As a consequence of experiencing difficulty with maintaining qualified staff, companies are often found to be noncompliant following an audit.

In response to facilities requesting our assistance in this matter, we have created Quality Training Online, an interactive online training site that provides GXP training courses and customized training platforms to the Life Science industry. These courses have been specially created to meet the regulatory requirements established by the EMA (European Medicines Agency), the FDA (U.S. Food and Drug Administration), and the MHRA (Medicines and Healthcare Products Regulatory Agency).

Click here to see a list of courses and learn more about qualitytrainingonline.com.

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