MedPharm will develop all necessary analytical methods applicable to the API, experimental matrix, formulation type, and presentation.

MedPharm’s philosophy is to try and develop the minimum number of methods for conducting forced degradation studies and stability-indicating methods. This is necessary to combine the detection of impurities and key excipients wherever possible. These methods will be validated to the appropriate level depending on the development stage of the project.

MedPharm looks to provide analytical data in the most appropriate visual presentation to aid client’s communication internally, with potential investors and when educating key opinion leaders.

To support formulation development MedPharm has sophisticated equipment for:

  • measuring particle size and rheological properties
  • predicting physical stability
  • measuring drug concentrations to picogram/ml concentration using modern LC-MS instrumentation
  • improving consistency and increasing throughput using a Hamilton Vantage robot

As part of a $4 million investment in their US facility, MedPharm has installed the latest Waters LC-MS/MS to manage the increasing demand for bioanalysis. This new model is equipped with UPLC for rapid separation and method development to offer cutting-edge mass spectrometry detection at picogram levels.

MedPharm’s experts do not just pass clients the data. In all circumstances, the team will interpret and recommend the next steps based on the individual goals of each client. This is possible thanks to MedPharm’s track record of supporting successful regulatory submissions.