We help biotech and pharma companies navigate the technical and regulatory challenges of developing and manufacturing drug products. Our team knows how to build practical, science-driven CMC (Chemistry, Manufacturing, and Controls) Consulting Services strategies that stand up to regulatory scrutiny and support real-world execution.
From early development through commercialization, we work alongside our clients to design scalable processes, generate reliable data, and get through regulatory milestones with fewer delays. Whether you're preparing for an IND, scaling up manufacturing, or managing post-approval changes, we make sure your CMC approach is solid, efficient, and built to last.
Built for What Comes Next
We partner with biotech and pharma companies to solve the technical and regulatory challenges of developing and manufacturing drug products. With a focus on science, practicality, and execution, we build CMC strategies that hold up under regulatory scrutiny and scale in the real world. From early development to post-approval changes, we help you move forward with confidence—fewer delays, stronger data, and a smarter path to market.
CMC Strategy & Regulatory Support
- Development and execution of comprehensive CMC strategies for small molecules, biologics, cell and gene therapies
- Authoring and reviewing of CMC sections for INDs, IMPDs, NDAs, BLAs, and MAAs
- Gap assessments and readiness evaluations for regulatory submissions
- Regulatory agency interaction support (e.g., pre-IND, EOP2, Type C meetings)
Process Development & Optimization
- Route scouting, process design, and optimization for API and drug product
- Technology transfer to CMOs/CDMOs
- Scale-up support from bench to GMP manufacturing
- Design of experiments (DoE) and process characterization
Analytical Development & Validation
- Development and qualification/validation of analytical methods
- Control strategy development for raw materials, intermediates, and finished products
- Stability program design and data interpretation
Supply Chain & Manufacturing Operations
- CMO selection and management
- Supply chain strategy and logistics support
Lifecycle Management
- Post-approval change management
- CMC updates for global regulatory maintenance
- Continuous process verification and improvements