Strategic Pharma Launch Services for First-Time Success

Bringing your first drug to market is complex. with over 500,000 ongoing clinical studies and nearly 1,350 organizations navigating their first clinical trial—78% still in early stages—the road to approval is crowded and competitive. Despite this, only 15-33 first-time drug launches secure FDA approvals each year. Many face late or failed approvals, with median delays exceeding 400 days.

To improve your odds, you need more than effort—you need expert guidance, strategic foresight, and a clear roadmap.

Our First-Time Launch Services help you bridge clinical success and commercial readiness through:

• End-to-end or targeted expertise
• Regulatory guidance
• Commercialization strategy
• Market readiness support

We understand that early-stage companies must be intentional about how and when they invest. That’s why we start with the end in mind—ensuring the right actions happen at the right time, with a partner who understands how today’s decisions shape tomorrow’s success.

Let’s accelerate your path to approval—faster, smarter, and with confidence.

A first-time drug launch demands a strategic, structured approach—tailored to your asset and agile enough to adapt. Our targeted services are designed to streamline commercialization using the right people, processes, and technology to set your launch up for success.

With NNIT’s full-service First-Time Launch engagement, we begin with an "As-Is" Discovery Assessment, evaluating your current business and IT processes to uncover gaps and opportunities.

From there, we apply our First-Time Launch Playbook—a structured framework that defines:

• Cross-functional workstreams
• Digital infrastructure and systems
• Validation requirements
• Resource planning

Our First-Time Launch Roadmap then translates strategy into action with a tactical execution plan detailing key milestones, regulatory and compliance checkpoints, and go-to-market strategies.