Analytical development

Holochem offers full EP/USP/ICH compliant analytical development support

Holochem offers full EP/USP/ICH compliant analytical development support

 

Holochem’s services include full EP/USP/ICH compliant analytical development support for drug substance and chemical development projects.

We are supported by a dedicated analytical team with in-depth regulatory expertise and have access to a wide range of analytical equipment.

 

 

Method development & validation

Analytical method development is an integrated part of the global drug development process. We recognize that prompt access to precise analytical information is crucial to accomplish process development projects in an efficient manner.

Our services in the field of method development and validation involve:

  • In-process method development
  • Method development for finished APIs
  • Definition of specifications and development of monographs

 

Reference standards identification & characterization

Our analytical development services also include the identification and characterization of process impurities, metabolites and reference standards, in compliance with EP, USP and ICH chemical reference standards.

Analytical data on product quality and impurities are used to develop efficient processes and facilitate scale-up and technology transfer.