Quality Assurance & Control, Regulatory Affairs

Quality Assurance & Control, Regulatory Affairs

pi helps you create and implement lean quality systems encompassing all necessary quality elements: production, laboratories, materials management, facilities and equipment, packaging and labeling, and ICH based quality program. Experience is the key to reliability, quality and success.

We can offer you specialised consultants with industry experience and a working knowledge of industry best practices.
We support you with the optimisation of business processes, science and risk based GMP practices,  improved training practices, achieve regulatory compliance and build quality into your products.

Services include:

  • Change management – ¬†Quality culture assessment, education and deployment
  • Regulatory support
  • Quality System development and improvements as per multiple standards
  • Compliance remediation
  • Supplier quality management improvement / implementation
  • Vendor and supplier audits
  • Change control systems
  • Quality Risk Management system deployment
  • Specification development
  • Inspection readiness
  • cGMP and MOCK audits
  • Post-approval activities