Once the unique properties of your drug substance are assessed, one of Mikart’s skilled Formulators is assigned to your project to determine complimentary excipients and a robust manufacturing process.
The quality target product profile (QTPP) is defined based on information gathered during Pre-Formulation (drug substance properties, evaluation of RLD), and the critical quality attributes (CQA) of the dosage form are identified. A risk-based approach is utilized to challenge potential variables in the materials and process and to determine appropriate controls and tentative specifications.
Mikart strives to produce quality formulations that meet your expectations as well as those of the FDA.
• Drug-Excipient Interaction Studies
• Container/Closure System Compatibility
• Quality by Design (QBD) Principles
• Scoring Evaluations
• Shipping Studies