Technical Consultancy for Advanced Therapy Execution
Aligning process, analytics, quality, and regulatory execution to accelerate time to market.
Process → Execution → Control → Release → Lifecycle
Services
Process Tech Transfer
- Gap analysis
- Pilot and engineering study support
- Digitally executable Master Batch Records
- Manufacturing training
Analytical & QC
- Method readiness
- Qualification, comparability, stability
- Digitally executable QC methods (LIMS-ready)
- QC training
CMC & Regulatory
- Global regulatory readiness (IND / BLA / CTA / MAA — US, EU, UK/MHRA)
- Control strategy execution
- Comparability and change control
- Inspection readiness
Partners
Pixel Systems — Digitization of documentation
Chorah Labs — AI-based project acceleration and documentation
Supernova Flow Cytometry — Manufacturing and QC personnel training
Chorah Labs — AI-based project acceleration and documentation
Supernova Flow Cytometry — Manufacturing and QC personnel training