GxP Compliance Services

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GxP Compliance Services

Our experts have in-depth knowledge in all GxP areas and support you in complying with regulatory requirements relating to cGMP activities through targeted quality management. From document creation for risk-based C&Q, validation of cleaning and manufacturing processes through to routine production. In addition, we provide support in the areas of training on GMP aspects, audits, supplier qualification and regulatory affairs and the development of quality management systems.

We can also support your existing quality systems and accompany you throughout the entire product life cycle. BakerHicks stands for comprehensive end-to-end compliance.

Services

  • QA for supplier and CMO management
  • Onboarding and training organisation (internal and external)
  • QA during all stages of the product lifecycle
  • Project processes standardisation
  • Qualification processes standardisation
  • Development and support of quality management systems
  • QA according to regulatory requirements (e.g. cGMP / ICH / 21 CFR) and valid guidelines (ISO, SHE, ASTM, ISPE) in the technical as well as operational area
  • QA for the aseptic and non-aseptic production of biological and chemical active ingredients and excipients as well as pharmaceuticals
  • Qualification of contractors / suppliers
  • QA Risk and Gap Analyses
  • Processing of compliance deviations, CAPA and change management
  • QA management of transfer projects
  • Specialists for Regulatory Affairs

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Further Capabilities