Concept to Clinic to Commercialization
We believe that drug development is both an art and science.
Our approach to multi-disciplinary integration delivers results faster to achieve the outcomes you, and your patients, deserve.
YOUR INTEGRATED PHASE APPROPRIATE CDMO
Energize your drug development process with the power of Pii, employing the art and science of synchronization to
achieve the outcomes you, and your patients, deserve.
PROJECT MANAGEMENT
From first contact to successful completion of your project, your project manager serves as your agent with access to Pii’s senior leadership and all functional areas enabling time-sensitive decisions and allocation of critical resources.
- Initiation
- Planning
- Execution
- Monitoring and Control
- Closure
A Word from Our Head of Project Management Office
“Our team’s passion will drive your program to the next key milestone by applying our expertise, collaborative style, and ability to streamline the complete drug development process.”
— Vishnu Dwadasi
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ANALYTICAL SERVICES AND R&D
Our analytical services team will explore every aspect of your drug product’s scientific properties, the understanding gained informs the development process in a way that drives seamless progress.
Pii’s R&D scientific team sets the conditions for success, carrying out their responsibilities with an understanding of your strategic business outcomes.
- Method Development and Validation
- Formulation and Process Development
A Word from Our Head of Analytical Services and R&D
“The diverse backgrounds of our R&D scientists enable a broad range of aseptic and non-sterile dosage form development. We bring your product ideas to fruition, and then leverage our internal engineering and quality expertise to ensure a scalable, robust drug product and manufacturing process.”
— Shawn Watson
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OPERATIONS
The foundation of every project, our quality experts are inseparably linked to all disciplinary functions driving our philosophy of continuous improvement.
- Continuous Improvement, Tech Services and Validation
- Manufacturing Services
- Packaging Services
- Supply Chain Management
- Facilities and Engineering
A Word from Our Senior VP, Operations and Strategic Initiatives
“With the goal of achieving better patient outcomes and a strategy of continuous improvement, our clients can expect a high-quality, results-driven experience each time they work with us. While our technical and scientific expertise attracts clients, our consistently reliable performance sustains the strategic partnerships that are so valued.”
— Sridhar Krishnan
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QUALITY
The foundation of every project, our quality experts are inseparably linked to all disciplinary functions driving our
philosophy of continuous improvement.
- Quality Assurance
- Quality Control
A Word from Our Senior Director of Quality Systems
“Our R&D scientists are singular in their purpose: to develop a pure, safe, effective, scalable and reliable product. Quality is designed into each product from the beginning.”
— Kenneth Lavin
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A Word from Our Director of Quality Systems
“Every project, regardless of its stage of development, begins with our experienced team developing robust analytical methods to facilitate flawless tech transfer and ensure seamless quality control all the way through commercialization.”
— Monique Mendoza
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REGULATORY
Our regulatory experts operate beyond cGMP and are in continuous communications with regulatory agencies to answer questions before they are asked.
- Documentation Support
- Regulatory Filing
A Word from Our Senior Director, Regulatory Affairs
“We offer comprehensive regulatory services under one roof starting from CMC strategy, implementation, FDA liaison, eCTD dossier preparation and submission to health authorities through final approval and post-approval life cycle management.”
— Veeranna Lolla
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