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GMP Consulting and Regulatory Compliance Service

 

The Pharmaceutical Consulting Alliance (PCA) offers a comprehensive consulting service on issues regarding GMP and Regulatory Compliance. All partners have many years of experience gathered in renowned pharmaceutical companies, e.g. as Qualified Persons, QA/QC Managers, Production and Development Managers.

As specialists and/or executives they bring in their knowledge from all relevant areas of the industry:
 

  • Aseptic / sterile manufacture
  
  • Quality Assurance
  • Biotechnological production
  
  • Quality Control
  • Solids production
  
  • IT/EDP
  • Production of APIs
  
  • Engineering (water systems, HVAC Systems)
  • Production of excipients
  
  • Pharmaceutical development

Our clients benefit from the unique competence centre of PCA.

The GMP Consulting and Regulatory Compliance Service we offer is comprehensive. A starting point for our service is very often a GMP Compliance or Mock Inspection. We identify the areas where the current compliance status needs to be improved. The Audit Report will summarise the GAP between the requirements laid down in the different legislations and Guidance documents and contains recommendations to close the GAP. In addition to this analysis, we can support you with the implementation of the recommendations into practice, e. g. by writing SOP's, Validation Master Plans and other Compliance documents. This includes the consulting service to prepare for an FDA or EU GMP Inspection. On this webpage you will find first information about the services we offer and about our partners. Please keep in mind that the experience of the consultants is essential for a good and successful consulting service.