Development Solutions

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Development Solutions

Home  Solutions Development

Advancing Development Solutions with Scientific Excellence

At PI Health Sciences, we deliver integrated pharmaceutical development services that transform clinical candidates into market-ready therapeutics. As your dedicated partner in drug development services, we combine process research, analytical excellence, and safety-focused execution to create value for biotechnology and pharmaceutical companies.

Our strength lies in a collaborative approach where cross-functional teams—including process chemists, analytical scientists, and safety specialists—work seamlessly to accelerate development timelines. This integrated structure enables efficient execution across all phases, from early-stage optimization through commercial manufacturing readiness.

Our globally connected teams remove traditional barriers between process development, analytical validation, and safety assessment. This unified ecosystem supports agile responses to evolving development challenges, a key benefit of our comprehensive pharmaceutical development services.

Powered by leading experts and advanced technologies—such as process simulation, AI-driven analytical tools, and robust safety platforms—we deliver high-quality drug development services tailored to diverse therapeutic areas. Our flexible engagement models ensure we adapt to your unique business needs with precision and regulatory excellence.

Integrated Drug Discovery

Process R&D

We offer agile and phase-appropriate process research as part of our broader pharmaceutical development services, focusing on route optimization, scale-up, and lifecycle management. Leveraging flow chemistry, green chemistry, and biocatalysis, we ensure scalable, sustainable, and efficient processes from early-stage to commercialization.

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Custom Synthesis and Manufacturing

Process Safety

Our safety evaluations are designed to meet the highest global standards. Using advanced infrastructure, we perform rigorous hazard assessments, thermal stability studies, and risk mitigation strategies—key elements of safe and compliant drug development services.

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Project Management

Our certified project managers streamline development timelines by integrating cross-functional expertise. Using advanced tools, they ensure precision tracking, seamless collaboration, and full regulatory alignment—critical for fast and compliant pharmaceutical development services.

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Biologicals

Analytical R&D

We provide end-to-end analytical development, including method development, validation, impurity profiling, and stability studies. With state-of-the-art instrumentation and adherence to global regulatory guidelines, our analytical support underpins successful IND, NDA, and ANDA submissions, forming a core part of our drug development services.

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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 pharmaceutical development services are led by a team of global experts across process R&D, analytical development, GMP and non-GMP manufacturing, and regulatory strategy. Our non-siloed team structure allows process chemists, analytical scientists, and scale-up engineers to collaborate in real time, accelerating outcomes and solving development challenges faster.

Our leadership team has deep experience in complex chemistries, high-potency compounds, and hazardous material handling. By fostering a collaborative culture within shared labs and digitally enabled infrastructure, we enable rapid decision-making and consistently deliver outstanding results across all drug development services.

Our Expert Team

At PI Health Sciences, our pharmaceutical development services are led by a team of global experts across process R&D, analytical development, GMP and non-GMP manufacturing, and regulatory strategy. Our non-siloed team structure allows process chemists, analytical scientists, and scale-up engineers to collaborate in real time, accelerating outcomes and solving development challenges faster.

Our leadership team has deep experience in complex chemistries, high-potency compounds, and hazardous material handling. By fostering a collaborative culture within shared labs and digitally enabled infrastructure, we enable rapid decision-making and consistently deliver outstanding results across all drug development services.

Contact Us

Connect with PI Health Sciences to explore how our customized pharmaceutical development services can streamline your molecule’s journey from concept to market with precision and confidence.