Signed in as:
filler@godaddy.com
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.
remediation: global medical device company
Hospital Medical Devices
Client: Major medical device firm under FDA Warning Letter
Challenge: Regulatory non-compliance requiring a $300M+ turnaround program amid quality issues.
Solution: Led a large-scale PMO with 150+ consultants, integrating AI-enhanced analytics (PowerBI, Alteryx) for risk assessment and process remediation.
Results: Completed on-time with $25M in savings, lifted FDA restrictions, and achieved $25M annual cost reductions through streamlined operations.
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
AI-Driven Supply Chain Optimization for Animal Health Pharmacy
Client: Leading animal health pharmacy
Challenge: Suboptimal inventory management leading to 87% customer service levels and frequent stock-outs.
Solution: Implemented AI-based forecasting models using ML algorithms and Python for demand prediction and supply chain reconfiguration.
Results: Boosted service levels to over 95%, reducing disruptions and enhancing operational efficiency in a regulated pharma-adjacent sector.
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.
