From Pre-clinical to Commercial, Laurus Synthesis offers the dependability our customers need with regard to solving complex chemistry and analytical challenges, on-time delivery and consistent global quality standards. Our development and manufacturing teams maintain a tight focus on performance at scale, continuous process improvement, securing and de-risking supply chains to provide an efficient, compliant, cost-effective and long-term commercial drug substance and drug product solutions.
Pre-Clinical | Phase I | Phase II | Phase III | Commercial |
Non-GMP & GMP Synthesis: Regulatory Statring Materials, Intermediates, API | ||||
Quick process development from Med Chem synthetic route Non-GMP/GMP scale up to analytical method development |
Route scouting and finalization Full Process Optimization using QbD approach pGTI evaluation Analytical method development and validation Manufacture of clinical supplies NDA filing support |
Tech transfer and large-scale commercial manufacture |
Pre-Clinical | Phase I | Phase II | Phase III | Commercial |
Non-GMP & GMP Clinical supplies | ||||
Pre-formulation studies Formulation feasibility studies |
Large volume OSD (Tablets, Capsules) manufacture Fully-serialized (Track & Trace) Tech transfer & scale up |
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Analytical methods development, transfer and validations |
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