Process R&D
Services

Innovating Scalable Solutions for Pharmaceutical Development

At PI Health Sciences, our Process R&D services deliver GMP and non-GMP APIs, KSMs, and RSMs from preclinical tox batches to commercial scale. Leveraging our extensive expertise, we design, optimize, and scale up routes with a focus on safety, quality, and efficiency. Our team excels in phase-appropriate process R&D, ensuring seamless transitions from early development to commercialization.

Operation Strategy:

• Phase-Specific Development: Tailored processes for each development phase.
• Efficient Scale-Up: Reliable optimization and validation for seamless tech transfers.
• Cross-Functional Support: Collaboration across IP, QA, DQA, EHS, SCM, and RA teams.
• Integrated Safety Studies: Comprehensive evaluations before scaling up.

Scientific Excellence:

• Route Design: Scouting, developing, and optimizing synthesis pathways.
• Key Capabilities: Expertise in salt/polymorph screening, impurity synthesis, and stability studies.
• Green Chemistry: Focused on process efficiency, waste reduction, and energy conservation.
• Advanced Reaction Techniques: From chiral synthesis to complex organometallic reactions.

Communication & Collaboration:

• Client-centric approach with regular updates.
• Proactive regulatory challenge anticipation and mitigation.
• Vendor engagement ensures timely and competitive raw material availability.