Development Solutions

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Development Solutions

Home  Solutions Development

Advancing Development Solutions with Scientific Excellence

At PI Health Sciences, we have engineered a comprehensive development platform that transforms clinical candidates into market-ready therapeutics. As your dedicated development partner, we integrate process research, analytical expertise, and safety protocols to create exceptional value for biotechnology and pharmaceutical companies.

Our strength lies in our integrated approach where cross-functional teams of process chemists, analytical scientists, and safety specialists collaborate seamlessly. This integration enables efficient execution across all development phases, from early-phase optimization through commercial manufacturing readiness.

Our globally positioned interdisciplinary teams eliminate traditional barriers between process development, analytical validation, and safety assessment. This collaborative environment fosters rapid problem-solving and agile responses to evolving development challenges.

Integrated Drug Discovery

Process R&D

Agile and phase-appropriate process research and development, focusing on route optimization, scale-up, and lifecycle management.

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Custom Synthesis and Manufacturing

Process Safety

Comprehensive process safety evaluations ensure that all manufacturing processes meet the highest standards of safety and compliance.

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crop solutions

Project Management

Experienced and certified project managers integrate cross-functional expertise to streamline development timelines.

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Biologicals

Analytical R&D

End-to-end analytical research and development services, including method development, validation, impurity profiling, and stability studies.

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Core Capabilities
Technological Strengths
Infrastructure & Capacity
Differentiators & Value Drivers
  1. GMP & non-GMP APIs, Intermediates, RSMs/KSMs
  2. High potency handling up to OEB4
  3. Analytical method development
  4. Stability studies
  5. Route scouting and optimization
  6. Greener, cost-effective process development
  7. Commercial-scale manufacturing
  • Flow Chemistry: One of the world’s largest plants (15 tons/day, 8-step process)
  • Biocatalysis: Sustainable enzymatic transformations
  • Green Chemistry: Waste and energy reduction focus
  • Handling complex reactions: Azides, Phosgenation, Fluorination, Chlorination
  • 330 kL manufacturing capacity
  • Potent molecule handling (down to 1 µg/m³)
  • State-of-the-art kilo labs
  • Digitally enabled operations
  • Global quality and compliance systems
  • Investment capacity: $600M earmarked
  • Speed in early-phase development
  • OTIF (On-Time In-Full) performance
  • Solution-driven approach
  • Scientific leadership (32 Process Patents)
  • Quality embedded across operations
  • Sustainability-first mindset

Our Expert Team

At PI Health Sciences, our Development Solutions team comprises world-class experts who bring a wealth of experience to every stage of the drug development journey. Our non-siloed structure empowers high-performing scientists to collaborate seamlessly across disciplines—process chemists, analytical specialists, and scale-up engineers working in unison to deliver innovative solutions.

Our leadership team brings deep expertise in Process R&D, Analytical Services, GMP/Non-GMP manufacturing, and Regulatory Compliance, ensuring every project is guided by specialized knowledge and strategic foresight. With proven capabilities in handling complex chemistries, hazardous materials, and high-potency compounds, we are uniquely equipped to address the most challenging aspects of drug development.

By fostering a culture of collaboration in state-of-the-art shared laboratories, our interdisciplinary teams ensure immediate communication, rapid decision-making, and rigorous quality standards. This adaptive and innovative environment enables us to accelerate timelines, overcome development hurdles, and consistently deliver exceptional results to our partners.

Our Expert Team

At PI Health Sciences, our Development Solutions team comprises world-class experts who bring a wealth of experience to every stage of the drug development journey. Our non-siloed structure empowers high-performing scientists to collaborate seamlessly across disciplines—process chemists, analytical specialists, and scale-up engineers working in unison to deliver innovative solutions.

Our leadership team brings deep expertise in Process R&D, Analytical Services, GMP/Non-GMP manufacturing, and Regulatory Compliance, ensuring every project is guided by specialized knowledge and strategic foresight. With proven capabilities in handling complex chemistries, hazardous materials, and high-potency compounds, we are uniquely equipped to address the most challenging aspects of drug development.

By fostering a culture of collaboration in state-of-the-art shared laboratories, our interdisciplinary teams ensure immediate communication, rapid decision-making, and rigorous quality standards. This adaptive and innovative environment enables us to accelerate timelines, overcome development hurdles, and consistently deliver exceptional results to our partners.

Connect Us

Reach out today to discuss how our tailored drug discovery and development expertise can accelerate your program’s success.