Services

Reliable Drug Substance, Drug Product Development and Manufacturing Services

Reliable Drug Substance, Drug Product Development and Manufacturing Services

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.


Drug Substance Services

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


Drug Product Services

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

Analytical methods development, transfer and validations

Niche Solutions

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