Drug Product Science: Solid Orals & Sterile Injectables
The science of drug product development is the foundation of everything. For solid orals and sterile injectables alike, we apply deep formulation science, rigorous Quality by Design (QbD), and proprietary Monte Carlo simulation to quantify batch failure risk before the FDA forces a specification you cannot consistently meet. We build methods with full DOE response surface knowledge — so we can dial release rate up or down with precision and defend every decision at filing.
- ✦ Immediate & Modified Release Dosage Forms
- ✦ Amorphous Solid Dispersions (ASD) & Lipid-Based Systems
- ✦ Statistical Formulation & Process Optimization
- ✦ Scale-Up Physics and Mechanistic Blending Models
Management of Science: From the Lab to the Boardroom
Good science poorly managed is still a business failure. The gap between the bench, the project, and the organization is where millions of dollars and years of development time quietly disappear. We use Linear Programming to optimize portfolio resource allocation, Lean R&D frameworks to compress timelines without cutting corners, and proprietary risk quantification models to translate CMC complexity into language that connects the lab to the boardroom — so leadership can make informed decisions instead of gambling on gut feel.
- ✦ Portfolio Optimization via Linear Programming — delivering more science on less budget
- ✦ Regulatory Risk Quantification framed for leadership and boards
- ✦ Technical CMC Due Diligence for acquisitions and in-licensing decisions
- ✦ Lean R&D and Six Sigma applied across global R&D organizations
Digital Strategy: Proprietary Tools That Change the Conversation
The pharmaceutical industry is moving fast in the digital space and most growing companies do not know where to start. We have built a suite of proprietary simulation and risk quantification tools that we deploy directly in client engagements — not as free public resources, but as client-facing deliverables that change the nature of every regulatory conversation. Clients receive branded, citable reports with failure probabilities, sensitivity analyses, and regulatory interpretation built in. This is what quantitative CMC consulting looks like when it is done seriously.
- ✦ Dissolution risk simulation with Monte Carlo batch failure probability
- ✦ Comparative dissolution profile analysis (f1 and f2) with regulatory interpretation
- ✦ DOE as a digital enabler — response surface knowledge that defends every filing decision
- ✦ AI and LLMs applied with scientific rigor in a regulated environment
Complex exits don’t have to be chaotic
While a checklist provides the roadmap, the execution requires a steady hand to mitigate risk and protect your assets. Let’s discuss how I can manage the heavy lifting of your restructuring.
EHS • HR • Asset Recovery • GxP
Strategic Restructuring & Facility Decommissioning
"Mitigating organizational risk by orchestrating compliant facility exits and workforce transitions through rigorous EHS protocols and change management."
We provide end-to-end oversight to ensure your reputation and bottom line remain protected during periods of significant organizational change.
- ✦ Human Capital: Designing retention strategies, severance frameworks, and outplacement frameworks that honor your team and retain critical knowledge.
- ✦ Asset Recovery: Managing equipment lifecycles—from decontamination certification to high-value redeployment or resale.
- ✦ EHS Compliance: 100% compliance with hazardous waste disposal, radiation safety, and GxP documentation archival.
- ✦ Site Closeout: Coordinating utility "safe-offs" and neutralizing lab environments to meet strict lease-end obligations.