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PCA - Pharmaceutical Consulting Alliance
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One-Stop Pharmaceutical Consulting Services

Benefit from a consultants team supporting you on all GMP and Regulatory Compliance matters – from GMP audits (current state analysis) to overarching advice and inspection preparation.

Build synergies.Auditing – Mock Inspections

  • Analysis of the current GMP status of a site
  • Audit report and improvement measures
  • Inspections of suppliers and contract manufacturers
  • Mock inspections and preparation for EU- and FDA inspections

Consultancy

We support you with the following measures:

  • Monitoring your projects
  • Creating documents for you
  • Building up your quality systems
  • Contacting medicines authorities for you
  • Helping you in obtaining a manufacturing authorisation
  • Advising you about applications for marketing authorisations for medicinal products and APIs (CEP/DMF)

 
We offer you consulting services for all relevant departments
and fields of expertise:
  • Aseptic / sterile manufacture
  • Biotechnological production
  • Solids production
  • Production of APIs
  • Production of excipients
  • Quality Assurance
  • Quality Control
  • IT/EDP
  • Engineering (water systems, HVAC systems)
  • Pharmaceutical development

 

   Our consultancy is based on the following standards::
  • FDA
  • EU/EMEA
  • WHO
  • PIC/S
  • Pharmacopoeias (EP/USP)