Providing Practical Science-Based Consulting to the Pharmaceutical Business.
Provides biopharmaceutical regulatory and manufacturing consulting services with strategic and hands-on experience to assist clients in bringing their products to market quickly and successfully
Well-founded in the pharma and biotech industry and focus on offering CMC and related services in Biologics and Biosimilars.
Process development
- Root cause investigations
- Writing of development reports and documents
- Manufacturing process development strategies
- Expert opinions on bioprocess development
- Get the most out of your development budget using Design of Experiments (DOEs)
Process characterization and QbD
- Design of and support to Process Characterizations programs
- Writing of reports and documents to support the common technical document (CTD)
- Support to reaching the right regulatory level
- Improve Process Control Strategies
- Design of continuous process verification programs (CPV)
- Lower the risk profile of your project
- Maximize the value of your project