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strategy: feasibility study for HIGH POTEncy drug production
Beaty Product Company
Our team reviewed high potency manufacturing options for U.S. based manufacturing for a high potency drug used in beaty products. This highly toxic substance require special considerations and has unique manufacturing setup requiring in-depth knowledge of manufacturing HPD.
We developed cost estimates, timelines and regulatory requirements with recommendation for potential locations for the board to decide whether to do HPD manufacturing in the new U.S.
amazon channel expansion with ai OPTIMIZED supply and prices
Medical Device Distributor
Our team led a data science-based price optimization effort and developed optimization models for a private equity-held medical device company with over 30,000 active marketed products resulting in a reduction of revenue leakage.
We developed machine learning-based Supply Chain Management optimization and forecast management models resulting in a reduction of stock-outs from 30%+ to 8% within 5 months. Developed accelerated process to list products on Amazon resulting in $50MM+ revenue from zero within 36 months.
animal health supply chain optimization
Compounding Pharmacy
Our client was experiencing lower customer service levels due to industry change to smaller, more frequent orders with shortened product expiration changes. These changes were driven by regulatory changes.
Our approach was to find the poor performing key levers with root causes. What we found was that the S&OP process was partial, inventory management was lagging significantly and skills and processes were suboptimal.
With our recommendations, the company was able to address customer service issue root causes and was successful in stepping up the performance.
combination device remediation management
Improve Design Controls
Legacy design controls caused the FDA Warning Letter but also the production facility age was posing challenges
Maintain Production
The combination device was live saving device and any reduction in production would mean putting patients' lives at risk.
Deliver Regulatory Agency Commitments
With Optimi's remediation management approach the company delivered all regulatory commitments made on time.
Manage Key Stakeholders
The company was part of a very large pharmaceutical company but was marketed by another generics company creating two large executive stakeholder groups who's expectations were growing.
FDA Warning Letter Remediation
Pharma REMEDIATION management
A mid-size pharma company had years of FDA Warning Letter (WL) remediation efforts without enough results. Our remediation method helped to lift WLand to launch new products resulting to a successful merger with a larger company.
