First-Time Launch Services
Strategic Pharma Launch Services for First-Time Success
Breaking Barriers: Navigate Your First Drug Launch With Confidence
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, within median delays exceeding 400 days.
To improve your odds, you need more than effort—you need expert guidance, strategic foresight, and a clear roadmap.
Your Strategic Partner in First-Time Launch
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.
Solutions for First-Time Launch Success
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.
A Proven Framework to Guide Your First-Time Launch
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.
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First-Time Launch Playbook
Ensure the success of your first commercial launch with a proven Playbook to manage risks and maximize readiness for pre- and post-launch activities.
Our Playbook provides a structured framework that defines:
Cross-functional workstreams
Digital infrastructure and systems
Validation requirements
Resource planning
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First-Time Launch Services
Tactical support to execute initiatives identified in the Playbook or pre-existing cross-functional plan to implement business critical and right-sized processes, partners, people, and systems.
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First-Time Launch Roadmap
Our Roadmap translates strategy into action with a tactical execution plan detailing key milestones, regulatory and compliance checkpoints, and go-to market strategies.
First-Time Launch Alliance
The First-Time Launch Alliance (FTLA) is the first group of its kind dedicated to the challenges of building a biotech company. Whether you’re in leadership, project management, operations, or a supporting role, this space is designed for you.
