Expertise
Pharmaceutical Development & Manufacturing
Compliance obligations do not begin at commercial launch. We work alongside development, technical operations and manufacturing teams so that the decisions made early — in formulation, process design, materials and documentation — hold up when the product reaches validation and commercial supply.
Across the product lifecycle
- GMP expectations during pharmaceutical development and clinical supply manufacturing
- Process design, process characterization and control strategy documentation
- Scale-up quality planning and readiness of the receiving site
- Technology transfer protocols, comparability and knowledge transfer
- Batch record design, review and right-first-time improvement
- Manufacturing investigations, yield and process performance issues
- Commercial manufacturing quality oversight and continued process verification
Building compliance into the process
Retrofitting compliance onto a process that was not designed for it is expensive. Our consultants have watched both outcomes from inside the Agency and from inside industry, and the difference is usually documentation discipline and control-strategy clarity established early.
We provide practical, hands-on support: sitting with process engineers, reviewing development reports, drafting protocols and challenging assumptions before they become validation problems.
Contract manufacturing
Many sponsors carry the compliance risk of manufacturing they do not perform themselves. We support CMO selection due diligence, quality agreements, person-in-plant oversight and periodic audits so sponsor oversight is real rather than documentary.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.