New Product Introductions (NPI)

We recognize that your drug product comes with its own unique challenges. Our new product introduction (NPI) and tech transfer processes ensures a smooth transition and high-quality results on time and on budget. We’ve manufactured complex and innovative drug products in collaboration with both global pharma companies and smaller biotech startups.  

Your project is led by a technical project manager acting as a single point of contact and supported by a network of scientists and manufacturing experts. Many of our team members bring years of floor experience alongside their project management skills, making them highly effective and knowledgeable across the entire product life cycle.  Whether it’s overcoming roadblocks or staying ahead of tight deadlines, we’re here to make your job easier. 

Above all, we prioritize keeping open lines of communication and providing frequent, real-time updates about your project’s status. You’ll always know where your project stands, and we’re ready to work through any challenges as your trusted partner. Our team of key account managers work with project managers to share information with you proactively and response quickly to any concerns, no matter the size of your project with us.   

Our project management and technical experts oversee clinical trial or commercial registration batches to ensure that all aspects of manufacturing process, including lyophilization, mixing, fill-finish, and sterilization, all meet the stated CQA (critical quality attributes) and function as intended. We also perform analytical method validation transfer, raw material qualification, PPQ (process performance qualification) batches, stability studies, and other services to ensure a smooth tech transfer.