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. Furthermore it is important to document what you are doing - efficiant and complete, because "only what is documented - was done"

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 completed and 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.

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

Topics

• 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 GDP and GVP
• Receipt of adverse drug reactions
• Product quality complaints, complaint management
• Implemenation and monitoring of risk minimisation measures (i.e. Educational material)
• Product management (updates, answering requests from authorities)
• Change Control
• Deviationmanagement
• CAPAs
• Auditprogram
• Risk Management
• Information management

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