Built to help Biotech companies scale with confidence

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Strategic leadership across the complete CMC lifecycle

The Problem:  Biotech companies often struggle with fragmented program management, leading to disconnected decision making, missed milestones, and inefficient resource allocation.  Without experienced leadership, critical CMC activities lack strategic coordination and oversight.

Our Solution:  We provide comprehensive product and program management that integrates all CMC functions - from early development through commercial launch.  Our approach includes cross-functional team leadership, milestone planning, risk mitigation strategies, and stakeholder communication that keeps programs on track and aligned with business objectives.

Ideal For:  Mid and late phase biotech companies preparing for regulatory submissions, organizations with complex multi-product portfolios, and leadership teams managing investor expectations around program execution.

From starting materials to fill finish:  Complete Network Optimization

The Problem: Geopolitical tensions, capacity constraints, and supply chain volatility are forcing companies to completely rethink their manufacturing strategies. Traditional approaches often leave companies vulnerable to single points of failure, while poor vendor selection and negotiation result in costly partnerships and operational risks.

Our Solution: We design and optimize external manufacturing networks that balance cost, risk, and scalability. Our comprehensive approach includes CDMO selection criteria, capacity planning models, contract negotiation support, and scenario-based risk assessment that accounts for regulatory, geopolitical, and market variables.

Ideal For: CGT companies with complex logistics requirements, organizations planning global market launches, and companies evaluating manufacturing regionalization strategies or facing CDMO partnership challenges.

When CDMOs disengage and timelines collapse

The Problem: Stalled tech transfers are one of the leading causes of program delays, investor concern, and regulatory risk. When CDMOs become unresponsive or manufacturing timelines slip, traditional consulting offers analysis—you need action and experienced leadership to salvage critical programs.

Our Solution: We step directly into crisis situations with hands-on leadership to restore momentum and deliver results. Our approach includes cross-functional team leadership, vendor relationship management, rapid decision-making, and technical problem-solving to deliver inventory on critical timelines.

Ideal For: Phase II/III programs facing CDMO failures, companies with upcoming regulatory submissions, and leadership teams managing investor expectations around supply continuity and program recovery.

Strategic Expertise without the full time overhead

The Problem: Many biotech companies need VP-level CMC and operations expertise but aren't ready for full-time executive hires. This gap often leads to fragmented decision-making, inconsistent vendor management, and missed strategic opportunities during critical growth phases.

Our Solution: We provide interim executive leadership that integrates seamlessly with your existing team. From organizational development and hiring strategies to regulatory submission support and investor communications, we bridge the gap between tactical execution and strategic vision while you build internal capabilities.

Ideal For: Companies building internal operations capabilities, organizations preparing for Series B/C fundraising, leadership teams managing rapid growth and scale-up decisions, and companies in transition between permanent leadership.

Regulatory scrutiny demands smarter preparation

The Problem: Regulatory agencies are intensifying cGMP compliance expectations, especially for novel modalities. Companies often discover Module 3 gaps or vendor compliance issues too late, resulting in regulatory delays, costly remediation, and failed inspections.

Our Solution: We deploy comprehensive assessment methodologies and scenario planning to evaluate inspection readiness months before regulatory contact. Our approach includes custom readiness evaluations, quality maturity assessments, vendor compliance audits, and simulated inspection scenarios that prepare your entire organization—not just your documentation.

Ideal For: Companies preparing for pre-approval inspections, organizations with complex supply networks, teams managing global regulatory submissions across US and EU markets, and companies seeking to minimize regulatory risk.

 BLA Isn't the Finish Line—It's the Starting Line

The Problem: Many biotech companies underestimate the operational complexity of transitioning from approval to successful commercial launch. Post-approval challenges—from inventory optimization and supply forecasting to vendor compliance monitoring and labeling oversight—can derail market entry, impact patient access, and create costly operational gaps during the critical launch phase.

Our Solution: We provide comprehensive commercial launch support that bridges the gap between regulatory approval and sustainable commercial operations. Our approach includes long-range planning and scenario modeling, inventory strategy optimization, labeling and regulatory compliance oversight, vendor performance management, and operational risk mitigation to ensure smooth market entry with fewer surprises.

Ideal For: CGT companies preparing for launch with lean internal operations teams, recently approved organizations transitioning to commercial manufacturing, and companies managing complex supply chains during market entry across multiple regions.