
PI Health Sciences
Integrated CRDMO combining 80 years of chemistry expertise with AI-driven discovery, development, and manufacturing solutions.
Integrated CRDMO offering end-to-end drug discovery, development, and manufacturing services with AI-driven capabilities, process optimization, analytical expertise, and GMP/non-GMP scale-up across small molecules and complex chemistry. Headquartered in Italy, Italy.
Phases
Services
- CMC Analytical Development
- Analytical Method Development & Validation
- Stability Testing & Storage
- Process Development
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- Flow Chemistry & Continuous Manufacturing
- HPAPI Manufacturing (High-Potency)
- Medicinal Chemistry
- Computational & In-Silico Drug Discovery
- Discovery Research
- Preclinical In Vitro Studies
- GLP Toxicology
- In Vitro ADME / DMPK
- Translational Research
- Regulatory Affairs
- CMC Regulatory Submission Support
Modalities
Technical specifications & accreditations
Accreditations
About this organization
Overview
PI Health Sciences is a leading Contract Research, Development and Manufacturing Organization (CRDMO) providing integrated solutions from discovery through commercial manufacturing. A subsidiary of PI Industries (founded 1946), the organization combines 80 years of chemistry expertise with modern AI and computational capabilities.
Discovery & Development Services
- Integrated Drug Discovery (IDD): Co-located teams delivering synthetic chemistry, medicinal chemistry, biology, and preclinical toxicology with AI/computational chemistry integration
- Chemistry Services: Molecular modeling, scaffold synthesis, impurity characterization, strategic IP evaluation, and route scouting
- DMPK Services: Drug metabolism and pharmacokinetics support
- Preclinical Services: Full preclinical toxicology and safety assessment
- Process Development: Discovery process chemistry, route scouting, process development, and process safety evaluation
- Analytical Services: Method development and validation, genotoxic impurity analysis, stability and forced degradation testing, potent compound analysis, trace metal testing, salt and polymorph screening
Manufacturing & Scale-Up
- GMP/Non-GMP Scale-Up: Phase-appropriate development from preclinical through commercial scale
- Manufacturing Services: Preclinical, clinical, and commercial manufacturing capabilities
- Process Safety: Advanced safety evaluations, hazard identification and assessment, thermal stability analysis, dust explosion testing, and engineering controls implementation
Enabling Technologies
- Flow Chemistry: Integrated flow chemistry services
- Biocatalysis: Integrated biocatalysis services
- In Silico Genotoxicity: Computational genotoxicity prediction
- New Modalities: PROTAC, LYTAC, molecular glues, AUTAC, and other targeted protein degradation (TPD) platforms
Regulatory & Quality
- Global regulatory compliance expertise supporting discovery to market
- Project management with certified project managers, agile methodologies, and cloud-based collaboration
- High potency compound analysis capabilities
Global Presence
R&D and manufacturing locations in Europe (Italy) and India (Hyderabad, Panoli, Jaipur, Ankleshwar), serving big pharma and biotech partners across the US, Europe, and Japan.
Locations
Headquarters
Italy · Europe · Italy
R&D and Manufacturing
Hyderabad · Telangana · India
R&D and Manufacturing
Panoli · Gujarat · India
R&D and Manufacturing
Jaipur · Rajasthan · India
R&D and Manufacturing
Ankleshwar · Gujarat · India
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