Analytical Method Development and Validation

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications. It provides a comprehensive coverage of method development and validation requirements to progress a pharmaceutical compound, at each stage of product development.

The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%. The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

Analytical methods  provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications. It provides a comprehensive coverage of method development and validation requirements to progress a pharmaceutical compound, at each stage of product development.Standard procedures are followed for same.

The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%. The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

  • Pharmaceutical analysis
  • Analytical support for pre-formulation and formulation
  • Quality control approach for formulation and development
  • X-ray Diffraction-Instrumentation
  • Computer and aid of software

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