We are independant CMC consultants, specialized in Biomanufacturing, providing strategic & operational support to biotech companies. 

At early stage:
- You need to anticipate the CMC requirements supporting IND/IMPD
- You plan to scale-up & transfer your process to a CDMO while preserving product representativity
- Your team must integrate the GMP culture to support the development of your product

At late stage : 
- You plan to modify your process for industrial performance or compliance constraints
- You need to transfer your process to a new production unit
- You must deploy a CMC strategy based on a robust Quality by Design approach

And in both cases,  you need to define the appropriate validation packages adapted to the regulatory requirements.

We support you in all these aspects of your product lifecycle by providing: 
- Strategic support as CMC & Biomanufacturing lead
- Operational support as Project manager
- Ad hoc expertise (audit, due diligence, technological assessment, troubleshooting...)

Alter Ego biotech

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