Consultancy services

 

Product Development

Bioproxus can provide consultancy services related to:

• Advise and support in all phases of product development (Design input, output, verification and validation)
  
  
• Design Control and Design History File conforming requirements of FDA regulations
  
  
• Process validation


• GMP manufacturing and upscaling
  
  
• Transfer of R&D process to commercial GMP production process
  
  
• Writing and review of technical documentation including protocols and reports related to R&D studies and pre-clinical studies, sterilization and stability, manufacturing processes and process verification and validation.
  
  
• Regulatory approvals including 510(k) and CE mark
  
  
• Technical, medical device related presentations
  
  
• Interim R&D management

 

Project Management

Bioproxus can provide consultancy services related to:

• Project Management of product development programs of biomedical devices