Biodrugs are our Passion Discover our World
Your experienced Biopharma Consultant
Our Services
1
BioPharma Consultancy
Bulk Drug Substance
- USP (mammalian, yeast and bacteria) and DSP support
- Process Characterisation Studies and PPQ
- Risk assessments
- Viral Clearance Study approach
- CMC Expertise
- IMPD, HA Questions and BLA support
Drug Product
- Formulation development
- Process Characterisation Studies support
- Risk Assessments
- Transport Validation, Drop Tests, Light exposure assessments
- CMC Expertise
- IMPD, HA Questions and BLA support
2
Technical Writing
For us technical writing is considered more as only writing. We generate a well structured document, you do not have time to compile. We perform statistical analysis and design clear visualisation of your data. We purpose an interpretation of your data, based on scientific knowledge.
For statistical analysis we utilize Minitab Software and for visualisation purpose of your data Spotfire.
We are looking forward to support you!
3
Project Management
We support you during Change Management utilizing the principles of lean six sigma methodology. For us lean six sigma is not only a concept for management it is a way you look on the enviroment and projects.
About us
Passion for Biotechnology
Biopharma Consulting is characterised by over 15 years of hands on experience in multiple topics during drug product development and commercial manufacturing: from drug product idea over process development, characterisation and transfer, FDA / EMA registration, commercial manufacturing, trubleshooting and quality assurance.