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  Quality & Regulatory Affairs

Quality Policy

To have commitment and involvement of the employees to do the things right first time, every time, in order to provide the consistently quality products and services, to meet and exceed customer expectations, with a focus on quality management system by fixing quality objectives and reviewing those periodically for continual improvement.

Quality Assurance Activities

  • Documentation & data control
  • Process validation
  • Change control
  • Facility auditing and implementing corrective actions

Quality Control Activities

  • Raw material testing
  • Packing material testing
  • In process testing
  • Finished product testing
  • Microbiological testing
  • Investigation
  • Reserve sample management

Regulatory capabilities

  • Successful filings of DMFs in USA and several other countries
  • Capabilities in submitting Certificate of Suitability (CoS) with EDQM and Commercial Technical Document (CTD) in Europe and several other countries
  • Capabilities in compilation of Chemistry Manufacturing Control (CMC) section of sNDA as a support to innovator pharma companies.

 

 

 

 

 

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