PreClinical Supply Services
Integrated Preclinical Manufacturing and Supply Solutions
PI Health Sciences delivers comprehensive Preclinical Supply Services designed to support early stage development programs with reliable, scalable, and strategically aligned manufacturing solutions. Our approach is built to ensure that early development is not constrained by supply limitations, but instead enabled through structured, responsive, and high-quality manufacturing execution. With a globally integrated operational network spanning India and Italy, we ensure uninterrupted supply continuity while consistently maintaining stringent quality standards and regulatory compliance across all stages of preclinical development. From the production of preclinical materials to the development of key starting materials and intermediates, our end to end manufacturing model is structured to deliver both precision and predictability. Each stage of supply is aligned closely with program timelines and development milestones, ensuring that materials are available exactly when required without compromising quality or consistency. This integrated execution model reduces delays, minimizes variability, and supports efficient progression across discovery and early development phases. At the core of our Preclinical Supply Services is an integrated framework that combines process optimization, regulatory compliance alignment, and lifecycle collaboration. Rather than operating as a standalone manufacturing function, our teams work in close coordination with development programs to anticipate challenges, optimize processes, and maintain continuity across stages. This collaborative and forward-aligned approach ensures that supply strategies evolve alongside program needs, delivering dependable, high-quality preclinical materials that support informed decision-making and sustained development momentum.Capabilities
End to End Preclinical Manufacturing
We support manufacturing from preclinical materials through key starting materials and intermediates within an integrated supply framework. Our structured execution model ensures alignment with early development timelines while maintaining quality and reliability.
Scalable Production Infrastructure
Our production capabilities include reactor volumes ranging from 50L to 10,000L. Specialized operational ranges support temperatures from -60°C to +160°C and pressures between 10 mbar and 6 bars, enabling flexibility across diverse process requirements.
Process Optimization & HPAPI Support
Process optimization strategies focus on improving yields and cost efficiency while maintaining scalability. We support HPAPI development from discovery through commercial scale within a controlled and compliant framework.
Quality & Regulatory Compliance
Operations are supported by ISO and GMP certifications, ensuring regulatory reliability and consistent product quality. Compliance alignment includes EU GMP and ICH Q7 standards, supported by multiple international certifications.
Global Network & Lifecycle Collaboration
Manufacturing sites in India and Italy enable integrated global supply execution. Continuous collaboration and round the clock support facilitate lifecycle management of APIs and ensure uninterrupted development progression.
Frequently asked questions
We’re here to help with any questions you have about our plans, supported features, and how our model works.
What does Preclinical Supply Services include?
Our Preclinical Supply Services provide end to end manufacturing support for preclinical materials, key starting materials, and intermediates required during early stage development. We ensure that manufacturing activities align with program timelines while maintaining structured quality and compliance standards. The integrated model supports early clinical candidates with reliable material supply, enabling seamless progression from discovery into development readiness.
What production capacities are available?
Our manufacturing infrastructure supports scalable production with reactor volumes ranging from 50L to 10,000L. Operational flexibility includes temperature capabilities from -60°C to +160°C and pressure ranges between 10 mbar and 6 bars. This range enables execution of diverse synthetic processes under controlled and reproducible conditions, ensuring adaptability across varying preclinical manufacturing requirements.
Does PI Health Sciences support HPAPI development?
We provide support for HPAPI development from discovery through commercial scale within a controlled and compliant manufacturing framework. Our approach integrates process optimization and scalable production strategies to maintain yield efficiency while adhering to stringent quality and safety standards. This ensures reliable handling of high potency compounds throughout development phases.
What quality standards do our facilities follow?
Our facilities operate under ISO and GMP certifications, ensuring structured quality governance and regulatory reliability. Compliance alignment includes EU GMP and ICH Q7 standards, supported by multiple international certifications. This framework ensures consistent manufacturing performance and regulatory confidence across global development programs.
Where are our manufacturing facilities located?
We operate manufacturing sites in Jaipur, India and Lodi, Milan in Italy. This global presence strengthens supply chain reliability and enables coordinated execution across regions. Round the clock operational support and integrated supply management ensure continuity and responsiveness throughout the preclinical development lifecycle.