IND-Enabling Services
Advancing Biologics Through Preclinical and IND Stages
Pharmaron provides scientifically rigorous IND-enabling biologics services designed to support the efficient progression of your biologic candidate from early development through regulatory submission.
Our multidisciplinary teams integrate expertise in cell line development, process development, analytical development, pilot scale production and GMP manufacturing, and toxicology studies to ensure seamless transitions across development milestones. By focusing on robust methodologies and quality at every step, we help you achieve IND readiness with precision and reliability.
Our Key IND-Enabling Services Include:
- Molecule (Developability) Assessment: Feasibility studies and biologic characterization
- Cell Line Development: Creation of stable, scalable cell lines
- Upstream & Downstream Process Development: Comprehensive optimization for production
- Analytical Development: Rigorous testing and monitoring
- Toxicology and CMC Services: Integrated non-clinical and regulatory support
- Regulatory Filing: Expert guidance for IND submission
Capabilities
IND-Enabling Workflow
Our structured development workflow ensures efficiency and compliance across all phases of biologics development. From molecule assessment to regulatory submission, we help you navigate complex processes seamlessly.
Workflow Highlights:
- Non-GLP and GLP studies
- GMP manufacturing options
- Pre-IND writing communication for FDA submission
Integrated CMC and Toxicology Support
Non-Clinical Development
Comprehensive CMC and toxicology services streamline IND preparation:
- Non-GLP Toxicology Studies: Identify and mitigate risks early
- GMP Comparability Studies: Bridge GLP and clinical studies seamlessly
- Documentation Support: Tailored CMC and toxicology documentation for regulatory readiness
Regulatory Preparation
Our expert teams ensure IND submission readiness with robust planning and execution:
- Risk Assessment and Mitigation: Address challenges proactively
- Regulatory Consulting: Develop submission strategies aligned with global standards
- Documentation Development: Prepare complete regulatory packages for CMC and non-clinical requirements
Ready to Learn more about our Comprehensive IND-Enabling Services for Biologics?
Speak with our experts to explore how Pharmaron can support your biologics program.
