Fermish offers comprehensive pharmaceutical regulatory affairs services suite. Our pharmaceutical regulatory consultant services offer the best solutions to meet all kinds of challenges for pharmaceutical, biotechnology, diagnostics and CRO industries. Pharmaceutical Regulatory Affairs consultancy is our one of the core strengths that helps iron out any hurdles in regulatory approval and compliance. Pharmaceutical Regulatory Affairs is as vital as data monitoring and management, for successful clinical trails and new product registration.

Our core pharmaceutical regulatory affairs expertise is in the following areas:

• Registration of foreign manufacturing plants and drugs including the following:
  
  

  • API
    
    
  • Formulation (including vaccines, rDNA products, blood products)
    
    
  • Medical devices
    
    
  • Diagnostics kits
    
    
• New drug approval for the following:
  
  

  • API
    
    
  • Formulation
    
    
  • Medical devices
    
    
  • Diagnostics kits
    
    
• Clinical Trial Approval
  
  

  • Phase I for Indian Discovery
    
    
  • Repeated Phase I
    
    
  • Phase II
    
    
  • Phase III
    
    
  • Phase IV
    
    
• Safety Reports Updating
  
  
• Import Licenses and permits for commercial and experimental use
  
  
• No Objection Certificate for conducting BA/BE studies
  
  
• Export permission/permit for Biological Samples from Directorate General of Foreign Trade,/Ministry of Commerce
  
  
• Clinical Trial Protocol Amendments Approval
  
  
• No Objection Certificate for export of Unapproved/Banned drugs