Erstellung und Implementierung von Prozessbeschreibungen

Process development

It is worth to continuously make actual snap shots of the company´s processes to assess interface issues and compliance. For example to identify weaknesses in compliance and communication, or to make a process which currently just work somehow robust and secure.

Appraisal

CSO Pharma conducts a mapping and takes stock of current issues or nonavailability of regulatory required processes. We issue a detailled report in order to plan the implementation and timelines accordingly. 

Process descriptions

As a result detected weaknesses could be corrected and the process can be optimised. We also prepare the necessary process descriptions (SOPs) to make the procedure accessible to everybody and ensure compliance with legal requirements. The process performed on random becomes reliable and save.

Topics

Just think about your processes in the following areas, are they compliant? Here we are your reliable partner with long term experience.

  • Organisation wide quality management
  • Training processes
  • Preparartion and management of contracts
  • Synergies of drug products and medical devices
  • Preparation and maintenance of master file(s) applicable to GMP, GDP, GVP
  • Processing of adverse drug reactions
  • Product quality complaints, complaint management
  • Monitoring and risk minimisation measures
  • Product management (updates, answering requests from authorities)
  • Good Manufacturing Practice (GMP)
  • Qualifcation and validation
  • Management of Clinical Trials (GCP)
  • Socialvigilanz
  • Information management
  • Using computerised systems

Please feel free to contact us to discuss your needs.
Your requirements are our key objectives.

CSO Services

We provide reliable Pharmacovigilance services, professional Medical Affairs support and succesful Quality Management and GDP Consulting >>

Contact

Do you have a question - please feel free to contact us.

T +49 (0) 89 2033 53 59
F +49 (0) 89 809 193 80

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