Product Life Cycle
We support you in developing scalable, preclinical and clinical production processes and support you in the technology transfer of your in-house
developed process into GMP production or to a contractor.
We make sure your batches are compliant and delivered in time and help you take cost-effective decisions.
Your product brought to the clinic quickly and efficiently
Activities
- Manage, plan and advice on
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- Process development and optimisation
- Preclinical and clinical GMP production
- Tech transfer and scale-up activities
- Batch release
- Review and write production, technical and quality documentation (process development and campaign reports, quality documents, CMC section)
- Support in and conduct root cause analyses
- Gap analysis of technology transfer/plant fit
Deliverables
- Scalable and compliant process design
- In time delivery of preclinical and clinical material
- High-quality, GMP compliant and well structured documents such as development report, campaign report, change requests, deviation reports, root cause analyses, batch disposition documentation
- Compliant production batches delivered in time
- In time delivery of tech transfer milestones
- Gap analysis
- Schedules for process development and optimization phases
Scalable production processes delivered in time
My experience
Multiple successful tech transfers from R&D to production and from pilot-scale to large scale
Batch success rate of >95%
10+ successful audits and inspections
Successful pre-approval inspection
Contact
Looking for support in tech-transfer or scale-up?
