Regulatory support

Holochem offers fully integrated EP/USP/ICH compliant drug development and IMPD/IND/DMF regulatory support throughout the entire chemical development process.

 

 

Standards compliance

Our project managers and scientists have thorough understanding of European regulatory guidelines. We deliver drug substances that comply with the EP, USP or ICH international standards.

Regulatory control

Our teams also have strong expertise and experience with regulatory dossiers. We can support our customer with the filling of their investigational files (IMPD and IND) and drug master files (DMF).