Fractional COO & FDA Remediation Services for the Life Sciences.

---

Interim VP of Operations/Product Development: Steering product development, manufacturing, and regulatory strategy during C-Suite vacancies to maintain investor confidence while ensuring cGMP compliance. Post-Bankruptcy/Turnaround Stabilization: Stepping in during or after financial distress to restructure operations, manage cash flow, and stabilize the workforce, focusing on profit growth and operational Remediation. Non-Dilutive Funding Strategy: Writing and managing budgets for DoD/BARDA/NIH grant proposals to secure non-dilutive capital, extending runway without giving up equity and contributing to revenue growth. Board & Investor Reporting: Translating complex operational data into clear financial and milestone reports for Board meetings and investor updates, enhancing transparency through consultation services.

Yield Improvement & Waste Reduction: By implementing Lean/Six Sigma methodologies within a cGMP framework, we can effectively address specific production failures to enhance First Pass Yield and drive profit growth. Inventory & Working Capital Optimization: Our consultation services focus on reorganizing production scheduling through Kanban and Demand Scheduling, which helps to lower inventory holding costs and free up cash for revenue growth. Standard Costing & Financial Modeling: We specialize in developing accurate standard cost models that properly allocate overhead, providing leadership with a true picture of unit economics and profitability. Forensic Engineering: Our experts investigate mystery product failures or efficacy issues to identify the root cause when internal teams encounter challenges, supporting effective remediation strategies.

Technical Transfer Leadership: Acting as the 'Technical Bridge' between your R&D scientists and the CDMO’s floor staff, ensuring that all processes adhere to cGMP standards and scale correctly for optimal profit growth. Global Supply Chain Architecture: Building complex, multi-national supply chains (e.g., Collection in US -> Processing in EU -> Distribution in US) with minimal internal capital investment, thereby enhancing revenue growth opportunities. CDMO Selection & Negotiation: Managing the RFP process, conducting technical audits, and negotiating Manufacturing Service Agreements (MSA) and Quality Agreements to protect your IP and margins while facilitating necessary remediation processes. Cost of Goods (COGS) Reduction: Reviewing Bills of Materials (BOMs) and manufacturing processes to eliminate waste and unnecessary label claims, directly improving product margins and supporting overall profit growth.

FDA Warning Letter Remediation: Immediate deployment of consultation services to manage responses to 483s and Warning Letters, ensuring cGMP compliance. We execute the CAPAs and validation work necessary for remediation to keep the facility operational and maintain revenue growth through continued product shipping. Sterilization Validation (EtO & Gamma): Designing and executing urgent validation protocols for sterilization processes under aggressive deadlines to meet regulatory compliance and support profit growth. Audit Defense & Preparation: Leading the front-line defense during FDA or Notified Body audits, managing the backroom, and drafting immediate responses to ensure robust compliance.