Our services
CMC & Biomanufacturing Lead
Execution
Ad hoc expertise
CMC & Biomanufacturing Lead
By your side, we are part of your team to manage CMC & and particularly GMP biomanufacturing topics (and much more as a biotech has no routine nor predefined journey …).
We bring an operational perspective on CMC strategy establishment and coordination from CDMO selection or implementation of GMP manufacturing facilities to process validation and regulatory submission.
Execution
We operate specific technical topics from an operational point of view, including the project management
- Process improvement (technology, scale-up)
- Tech transfer (risk assessment, technical studies and comparability)
- Quality by Design implementation (Methodology, training, execution)
- Process Validation strategy (from Process design to Continued Process Verification)
Ad hoc expertise
We support you ponctually to manage specific situations when you need an external point of view providing experience & benchmark
- Due Diligence
- Technological assessment
- Troubleshooting
- Audit
Billing practices
Fixed price contract
Fixed price contract gives you insurance to get results within pre-defined budget and mission scope
Time-based contract
Looking for flexibility ? Time based contract offers the highest flexibility for your project. You keep the control with monthly meetings summarizing spent vs remaining time, reallocation on the high priority topics.