Development of a robust, reproducible, cost-effective, and cGMP-compliant manufacturing process is critical for clinical and commercial success. The experts at Dark Horse know from personal experience that this is easier said than done and we’re here to help you navigate this challenging path. Our most widely-requested service and support options include:
We compile the data from your lab notebooks, study reports, and batch records into a comprehensive tracking-and-trending database. We evaluate this data using statistical analysis software to help you understand your process performance and trends.
We help you define and describe your process for regulators and CMOs. Our standardized frameworks have proven track records of success in regulatory filings and technology transfers.
We help you to perform a gap analysis of your current process and develop a comprehensive process and product development roadmap. We identify key items to be addressed at each stage of clinical development. We also assist you in developing your comparability plan to support those process changes.
We design a customized roadmap for establishing comparability to ensure that manufacturing changes (be they in location or process or both) are satisfactorily comparable, streamlining your future regulatory needs. We have extensive experience in study execution, data analysis, report writing, and drafting and submitting regulatory filings; we are also available to represent you at regulatory meetings to discuss those filings.
We advise, assist or lead methods to remediate process and test method failures, whether in-house or at your CRO/CMO.