PreClinical Supply Services
Integrated Supply Services Across the Drug Development Lifecycle
At PI Health Sciences, supply is not treated as a downstream activity, it is engineered as a continuous, lifecycle-integrated function spanning preclinical development through global commercialization. Our Supply Services framework is designed to ensure that material availability, manufacturing scalability, and regulatory compliance evolve in parallel with your program, eliminating bottlenecks and enabling uninterrupted progression across development stages.
By integrating preclinical, clinical, and commercial supply within a single operational model, we align process execution, quality governance, and global infrastructure to deliver consistent, high-quality materials at every phase. This approach minimizes variability, reduces transition risk between stages, and ensures that manufacturing and supply strategies remain aligned with both development timelines and long-term market objectives.
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 Support
Process optimization strategies focus on improving yields and cost efficiency while maintaining scalability.
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.
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.
Contact Us
Connect with PI Health Sciences to explore how our integrated preclinical supply capabilities can support your development programs, from early material generation and formulation support to scale-up, GMP-aligned production, and reliable supply for preclinical studies and IND-enabling activities.