Commercial Launch

Typically initiated ~36 months pre-launch, this is the earliest and most strategic commercial launch engagement.

• Development of preliminary commercial strategies
• Cross-functional information gathering and assumption alignment
• Documentation of key interdependencies, risks, and decision points
• Creation of a phased roadmap to guide downstream commercialization activities

This offering is often conducted ~24 months pre-launch, either standalone or in conjunction with a roadmap.

• Assessment of progress against internal plans, milestones, and company goals
• Benchmarking against industry peers and best practices
• Identification of gaps, risks, and critical dependencies
• Practical mitigation recommendations to de-risk the path to launch

Typically performed ~12 months pre-launch to confirm readiness and surface late-stage risks.

• Evaluation of launch preparedness across functions
• Assessment of governance, decision-making, and accountability
• Alignment of stakeholders on critical success factors
• Development of accelerated action plans to close gaps and reduce risk

We offer execution-focused support that follows strategic launch planning.

• CMO selection, tech transfer, and ongoing management
• 3PL and FTZ selection, onboarding, and setup
• Packaging, labeling, and artwork management
• Commercial supply and quality agreements
• S&OP and inventory planning processes
• DSCSA/serialization and enterprise system enablement
• Shipping solution design and qualification

Engagements typically begin with a focused strategic assessment and transition into long-term operational support.

Strategic services include:

• Global logistics and trade compliance gap assessments
• Evaluation of import/export practices, cold-chain readiness, and compliance risk
• Development of global logistics and trade compliance strategies and roadmaps

Operational services include:

• Acting as the client’s logistics and trade compliance function
• Day-to-day import/export execution for DP, DS, API, and R&D materials
• Building and maintaining trade compliance infrastructure, procedures, and supplier relationships
• Cold-chain and cryogenic logistics solution design and shipping qualification

We support the business side enablement of enterprise system initiatives without acting as a technical integrator.

Strategic services include:

• IT landscape and system assessments
• Solution selection for ERP, QMS, EDMS, serialization, COI/COC, MES, and analytics
• Business and user requirements definition

Operational support includes:

• Project management and PMO support during system implementations
• Test script creation, execution support, and UAT coordination
• Cross-functional coordination alongside third-party integrators

For clients currently without internal leadership in this domain, our senior experts can provide interim expertise and hands-on leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.

We oversee your project to achieve your milestones in a timely fashion, including maintaining up-to-date project timelines, organizing project team meetings, capturing meeting minutes, establishing RACI (responsible, accountable, consulted, informed) matrices, and following up on achievement of action items.

We both are your target customers and work with your target customers every day. Living amidst the technical details of this space has provided us with an understanding of what your customers are looking for, what their pain points are, and what messaging will resonate with them. We know how to strategize effectively in biopharma, no matter what your stage of market readiness may be.