A Guide To Successful Product Launches For Small And Midsized Biotechs

By Abhijit Naravane, PA Consulting

In the dynamic pharmaceutical industry, successful product launches are critical to business success. For small and midsized biotech firms, where the reliance on a few key assets is high, the stakes are even greater. For operations leaders, successful product launches represent a pivotal moment, often determining the company’s trajectory. These leaders must navigate operational constraints with strategic precision to unlock the full potential of their innovations. This article outlines strategies to navigate the complexities of a pharmaceutical product launch effectively.

Why Operational Excellence Is Critical For Launch Success

Pharmaceutical product launches carry both substantial opportunities and risks. Many launches, however, are impacted by operational inefficiencies — ranging from supply chain disruptions and regulatory hurdles to manufacturing delays. These challenges can derail market entry, delay the availability of essential products to patients, and undermine revenue potential. Based on a recent Tufts study, each day a launch is delayed can cost approximately $500,000 in daily lost revenue, highlighting why operational excellence is so critical.

It’s also important to note that these challenges are not limited to the launch date but extend throughout the entire commercial phase. This is because companies must continue to meet growing production demands, maintain supply chain agility, and ensure compliance over time. Companies that invest in robust operational processes, systems, and scaling of capabilities are better equipped to mitigate these risks, ensuring timely launches and optimizing market outcomes.

For smaller firms, the stakes are even higher. A single launch can account for a significant portion of the company’s value. In these cases, operational excellence becomes a necessity — not just to avoid delays, but to protect market share and fuel long-term growth.

To stand out, firms must prioritize five core imperatives:

• Supply chain agility: Build an agile and integrated supply chain network that can rapidly respond to demand changes and accelerate launches 
• CDMO partnership management: Foster strategic partnerships that enhance flexibility and ensure seamless technology transfer and production readiness, while optimizing costs
• Quality system excellence: Develop “fit-for-purpose” QMS to proactively identify and mitigate compliance risks that could cause delays
• Data-driven launch governance: Establish governance systems which leverage real-time data analytics for seamless coordination and decision-making during launches
• Operations capability scaling: Scale capabilities by aligning talent, processes, and technology to transition operations into a fully developed launch engine

By focusing on critical improvements, operations leaders can unlock significant operational efficiencies, reduce time-to-market, and achieve better cost management. If we unpack these core imperatives further, each has a multidimensional role to play in achieving launch excellence.  

Supply Chain Agility

Building supply chain agility requires a fully integrated approach, ensuring that suppliers, internal and external manufacturing, and distribution networks function as cohesive systems rather than independent units. This integration ensures that each component works in unison, providing end-to-end visibility and the ability to respond rapidly to changing demand and market conditions. However, achieving such integration can be challenging, particularly when dealing with uncertain demand patterns, tight timelines, or resource constraints.

In the case of supply chain disruptions — from raw material shortages to shifting demand — these risks can delay product launches and impact long-term success. Addressing these hurdles requires a strategic focus on alignment, collaboration, and adaptability across all stakeholders. For example, adopting scenario-based planning utilizes data-driven models to forecast potential demand fluctuations and develop contingency plans, while implementing a tiered pricing model based on order volumes and sharing long-term commitments fosters collaboration with suppliers, enabling better planning and more efficient execution.

Further, it is important to ensure cross-functional integration to drive collaboration across teams. To manage supply chain variability and risks, aligned performance metrics and the establishment of cross-functional task forces are key for success.

Securing Strategic CDMO Partnerships

Strong partnerships with Contract Development and Manufacturing Organizations (CDMOs) are critical to ensuring production flexibility and launch readiness. Given the pivotal role CDMOs play in both clinical and commercial production, obtaining overall alignment between their priorities and launch requirements is essential.

However, securing top priority from CDMOs can be challenging due to the high demand for their industrywide services. To gain priority, companies must position themselves as reliable, strategic partners, capable of fostering collaborative relationships and negotiating well-defined, performance-driven agreements. This approach helps ensure scalable production, reduces the risk of supply chain disruptions, and maintains product quality.

There are several leading practices to consider when managing CDMO partnerships. First, leaders should develop customized playbooks that include tech transfer protocols, scaling strategies, and validated recipes. These playbooks should incorporate a clear roles and responsibilities matrix, defined critical process parameters (CPPs), and a step-by-step guide for contingency management. Second, leaders should design strategic and outcome-focused agreements that secure reserved production capacity at competitive fees. Payments should be linked to specific milestones and performance metrics, ensuring accountability for timelines, quality, and cost efficiency.

Third, leaders should implement joint capacity and risk planning by co-developing production plans, conducting proactive risk assessments, and establishing clear escalation paths to ensure resilience to demand fluctuations and the swift resolution of critical disruptions.

Enhancing Quality Management Systems

Quality-related issues are key contributors to product launch delays, especially when ensuring compliance with CMC (Chemistry, Manufacturing and Controls) requirements. These delays often stem from legacy, paper-based processes initially designed for clinical operations, which may not effectively scale to meet the demands of commercial manufacturing. This misalignment often leads to inefficiencies such as data silos, which cause bottlenecks during quality approvals and production schedules. For organizations with limited budgets and legacy systems, scaling quality management processes to support commercial production can be particularly challenging.

Quality management can pose a unique challenge. Non-compliance with regulatory standards leads to costly setbacks, affecting product quality and launch schedules. At the same time, an overly burdensome QMS can hinder speed. To overcome these challenges, companies must implement a QMS that balances regulatory requirements with operational efficiency, prioritizing key process controls that directly impact compliance and product quality. AI can play a significant role in managing and maintaining this balance. AI-powered tools can assist with routine tasks, such as reviewing paper-based documentation for compliance, flagging inconsistencies in recorded data, and identifying potential quality issues. By automating these processes, AI can help prioritize actions and ensure that quality standards are met without overburdening existing systems.

Training and continuous improvement are equally important, and organizations can leverage AR/VR technologies to create simulations of critical quality processes and on-demand microlearning modules to reinforce key concepts and address skill gaps.

Data-Driven Launch Governance

Next generation "Launch Command Centers" (LCCs) empower operations leaders with real-time insights and advanced analytics for faster, more informed decision-making. These centers are crucial when resources are stretched thin, and teams must manage multiple priorities under tight timelines. By centralizing data across functions, LCCs ensure teams stay aligned with goals, minimize miscommunication, and prevent bottlenecks. This unified platform allows organizations to anticipate challenges — such as regulatory changes, evolving competition, and market shifts — and craft proactive, resilient strategies.

So how can companies successfully establish an LCC? Factors for success include:

• Establishing decision support systems: These centralized real-time dashboards provide a unified view of key KPIs across functions, integrated with advanced visualization and analytics. For example, if the order-by date is approaching and the material hasn’t been ordered, the dashboard triggers an alert, prompting immediate action to prevent production delays. Additionally, if demand exceeds projections, an AI optimization tool can estimate the total costs of expediting production and supplying materials, helping the team decide whether to absorb the additional costs or adjust plans.
• Conducting simulated launch readiness checks: Dry runs help assess end-to-end operational readiness and identify and resolve any operational issues prior to the official launch. For instance, a simulated run might uncover discrepancies in shipment lead times from an international supplier (not factoring in customs clearance and potential delays), prompting adjustments in the logistics plan and helping ensure smoother execution during the actual launch.
• Implementing cross-functional data integration: Platforms that integrate data across R&D, regulatory, manufacturing, and commercial teams improve communication and alignment, reduce bottlenecks, and accelerate decision-making.

Operations Capability Scaling

As product launches move from clinical trials to full commercialization, organizations often face the challenge of scaling operations effectively. Scaling operations involves not just ramping up production capacity but also refining processes, systems, and team structures to support commercial growth. The challenge lies in maintaining operational flexibility while ensuring that systems and teams are aligned to handle the growing demand. Key to success is building a strong operational infrastructure that can manage both the volume and complexity of commercial activities while ensuring quality, compliance, and optimal cost structure.

To do this, it will be important for leaders to focus on three areas: process optimization and monitoring, technology integration, and workforce capability building.

Standardizing workflows ensures efficient task execution, optimizing processes by reducing variability, improving accuracy, and streamlining operations. Continuous performance monitoring and best practices keep processes agile and scalable as the business grows. Simultaneously, leaders should maximize existing system functionality by fully utilizing features and leveraging fit-for-purpose technology solutions to support automation, data integration, and real-time analytics.

It is important, however, not to forget about talent. Building a culture of leadership that focuses on future-proofing operations is equally essential. Preparing the workforce by aligning learning programs with key operational metrics and improvements observed during day-to-day activities will continuously upskill teams and keep them motivated.

Looking Ahead

In the competitive world of pharmaceuticals, a successful launch can redefine a company’s trajectory. Operations leaders must champion a culture of operational excellence, combining strategic vision with executional rigor. By embracing data-driven strategies, fostering cross-functional collaboration, and prioritizing operational agility, operations leaders can position their companies for sustained success. Each launch presents a unique opportunity — mastering it requires foresight, preparation, and an unrelenting focus on excellence, without compromising the speed required to seize market opportunities.

About The Author:

Abhijit Naravane is a Partner at PA Consulting. Abhijit has over 15 years of strategic leadership experience in the pharmaceutical and life sciences sectors. His expertise ranges from shaping operations strategy to executing large-scale end-to-end transformation initiatives. At PA Consulting, Abhijit works alongside the firm’s life sciences clients to optimize their operations and achieve sustainable growth.