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Our Commitment To Aligning Objectives PDF Print E-mail


Our commitment to you is to be a partner in achieving your goals. At Avid Bioservices® we apply the following basic principles during the contract management process to ensure we achieve your goals.

 


  • Design appropriate processes for your needs
  • Model your process prior to cGMP manufacturing
  • Communicate so there are no surprises
  • Implement appropriate processes and control steps
  • Manage the project to meet timelines
  • Validate appropriate processes and methods
  • Report project status in a timely manner
  • Interact effectively with you the customer
  • Analyze data
  • Audit suppliers and processes
  • Interpret data and process effectiveness or need for changes
  • Adapt to changing customer requirements

Once we have mutually agreed to the scope of your project and an agreement has been executed, the Contract Manager will coordinate the process and become your key point of contact. The Contract Manager will work closely with you to fully define your requirements, the timing of your clinical trials and project plans to ensure that all your deadlines can be met. The Contract Manager will keep you informed of progress on a regular basis by your preferred method of communication. Regular project meetings ensure that all scientific issues are thoroughly reviewed scientist to scientist.

 

The Contract Manager at Avid Bioservices will coordinate the efforts of diverse multidisciplinary team to ensure the successful completion of your project. Typical project teams will consist of representatives from process development, bioreactor development, purification, manufacturing, analytical development, QA/QC and regulatory compliance, all working in a coordinated fashion, towards a common goal.

If required, your Contract Manager will work closely with you to develop a program for pre-BLA studies encompassing process optimization, product specific assay validations, consistency studies and product characterization. As your product moves into later phase clinical trials, and once your product is sufficiently characterized, your Contract Manager can coordinate a Supply Agreement to ensure a continual long-term supply of your product at the desired quantities. Your Contract Manager will also work closely with Avid Bioservices' regulatory team to provide relevant data to the appropriate regulatory authorities.