What Is NPI, Really? And Project Management’s Role in the Process

Successful project management of a new product introduction (NPI) in the pharmaceutical or life sciences sectors requires a unique leader. Ideally, a project manager will have equally balanced technical skills, such as first-hand qualification and validation experience, with strong relationship-building, persuasive communication, and conflict-resolution skills.

In large pharmaceutical companies, experienced NPI project managers, especially those with a background in validation and qualification, play a critical role in building realistic, compliant schedules that keep launches on track.

New product introduction can be challenging, particularly within regulated industries. Without proper planning and execution, compliance issues, and/or operational delays could occur. This article will first explain the types of NPIs and then how the project management role fits into the larger picture of the cross-functional team required for NPIs.

Understanding the Types of NPI Projects

Not all NPIs are the same. They range in complexity and scope, and each type benefits from a project management approach to manage risk that is specific to the needs of the project:

• R&D NPIs: These projects involve a technology transfer from R&D. They are dependent on the product type, e.g., device, biologic/drug, combination, etc., so a different approach may be taken on the path to commercialization. These launches rely on careful planning by cross-functional teams at each step of the product development through commercialization phase.
• Legacy NPIs: These typically involve technologies and products acquired from another organization or company. They can be simpler than full R&D efforts but still require a great deal of coordination and planning to take place across regulatory, quality, and other functions.
• Market Expansion NPIs: This can often be the most straightforward process but still fairly detailed, these projects focus on changes like artwork updates for new markets. In comparison, these projects might be simpler but effective communication, approvals, and documentation remain essential.
• Product Packaging Change NPIs: Product packaging may continue to evolve during a product’s lifecycle. Form, fit, and function changes to product packaging can also warrant new product introductions. Impact on regulations and operations necessitate these projects being treated as new introductions due to the detailed efforts it takes to make these a cross-functional success.

Each NPI type introduces its own considerations like team members, timelines, and milestones. An experienced project manager can scale processes effectively while balancing compliance, communication, internal policies, and control.

The Bigger Picture: NPI Project Management

Successful new product introductions in pharmaceuticals and other regulated industries demand tight cross-functional coordination. A typical structure involves a Program Manager overseeing the broader initiative, with Project Managers leading activities across each phase. This ensures alignment between R&D, brand, commercial, engineering, QA, packaging, and supply chain teams ahead of a product launch.

But NPI is an all-encompassing task and therefore project management needs to communicate with many stakeholders. Here is a sneak peek:

Key Functional Teams Involved in NPI

• Brand teams act as the central hub, pulling in input from all departments. Their goal is to meet commercial expectations and ensure that products are available for global markets. NPI project managers work closely with brand leads to manage Change Plans and coordinate launch timelines.
• NPI Project Managers ensure the site readiness for upcoming product launches. They schedule and facilitate cross-functional meetings, work with subject matter experts to complete project milestones, and keep stakeholders aligned on timelines and project deliverables.
• Regulatory Affairs often determines target filing dates and the rest of the team works toward building a timeline to accommodate or provide feedback when target dates are not adequate. These deadlines guide project managers in planning key qualification activities like engineering studies, material readiness, and compliance testing (e.g., child resistance or human factors).
• Operations manages the manufacturing floor and ensures labor is available for scheduled runs. They focus on productivity and equipment performance. Project Managers generally work with Operations to ensure that Validation and Engineering have support operating the equipment and/or inspecting the product as part of Engineering studies or Validation protocol testing. Operations also supports with Demonstration runs prior to commercial production to ensure there are no major risks during Process Performance Qualifications, for example.
• Validation handles both equipment and process qualification. If a new product will run on a packaging line that is new to this product format, the NPI Project Manager will coordinate with Validation to write and execute protocols, confirm the line produces consistent, in-spec product, and ensure all documentation is in place before the first commercial batch.
• Plant Engineering installs, maintains, and configures packaging equipment. NPI Project Managers work with engineering technicians to confirm that equipment recipes are ready before production.
• Labeling Team develops packaging artwork. They integrate inputs from sales and marketing, regulatory, and packaging teams to deliver approved artwork in time for printed material procurement. These steps are essential to the NPI Project Manager’s timeline.
• Packaging Engineering creates all technical documents related to packaging form, fit, and function for everything from case prints to pallet patterns, including document revisions.
• Materials Management includes both planning and procurement. Planners coordinate production schedules and commodity buyers ensure that all packaging materials are sourced on time.
• Supply Chain Planning communicates long-term demand needs from commercial teams and then applies this planning across sites.
• Quality ensures all processes comply with cGMP standards. They’re involved in every stage of the NPI process from incoming inspections to system validations.
• Finance is responsible for final costing of products and materials, a prerequisite before procurement and production can begin.
• IT Operations teams manage systems that track packaging materials and guide shop floor instructions. They are key in setting up the launch digital infrastructure.
• Value Stream Leaders in Lean-focused organizations oversee specific product formats (e.g., bottles, syringes, blisters) and ensure process accuracy, efficiency, and compliance. They’re essential for validating technical documents and resolving packaging issues.

Conclusion

Bringing a new pharmaceutical product to market involves a multi-departmental effort. A skilled NPI Project Manager possesses the technical skill, the desire to foster collaboration, and deep knowledge of regulatory requirements to align this cross-functional team and ensuring all elements are synchronized for a successful launch.

Contact us today to learn more from one of our experts about how our project management service can deliver for your organization and your NPI project.