Regulatory guidance documents state that it is imperative to detect polymorphic, hydrated, solvated, and amorphous forms of the drug substance during drug development.  Once all phases are identified, a thorough phase map and rationale for choosing a certain phase must be included in the general properties section of chemistry manufacturing and control (CMC) sections of the dossier.  If drug product safety, performance or efficacy are affected by the presence of undesired phases, there is a requirement to set acceptance criteria for polymorph content in the drug substance and/or drug product.  Crystal Pharmatech has years of experience in submitting dossier data.  Our research team understands the criticality of mapping out thermodynamic regions for all relevant phases in order to produce and maintain the desired phase throughout the entire API and drug product process.  When acceptance criteria are necessary, we have extensive experience developing, validating, and transferring analytical methods to detect low levels of undesired phases in both API and drug product.

• ●　Provide data for regulatory filings
• ●　Respond to regulatory questions