• Providing expert guidance and support for GxP compliance, including regulations such as FDA 21 CFR, EU GMP, and ICH Q7A
  • Assisting with the development and implementation of quality management systems that meet regulatory requirements
  • Conducting gap assessments and risk assessments to identify areas for improvement in current processes
  • Providing training and education on GxP regulations and best practices
  • Supporting audits and inspections by regulatory agencies
  • Assisting with the creation and maintenance of standard operating procedures (SOPs) and other quality-related documents
  • Providing ongoing support and consultation to ensure ongoing compliance with GxP regulations
  • Offering a range of services, including validation, change control, and deviation managementHelping organizations achieve and maintain regulatory compliance, while also improving overall quality and efficiency of processes.