What we offer -
Analytical Sciences
General support and guidance for pharmaceutical and biotech companies from lab bench to market
Analytical consultancy:
- Tailor-made analytical strategies for every development phase (pre-clinical to Phase III)
- Highly specialized in complex nanomedicine characterization and advanced analytical techniques (DLS/SLS, AF4-MALS, CE, etc.)
- Traditional small-molecule analytics (HPLC/UPLC, NMR, GC, etc.)
- Phase-appropriate development strategies that reduce risk and improve decision-making
- Method transfer, development, validation & troubleshooting
- Analytical life cycle management
What we offer -
CMC, PM and Lab
CMC (in accordance with GMP/ICH guidelines)
- Documentation setup and design (e.g. for Method validation, Stability studies, Forced degradation studies)
- CQA definition and control strategy
- Specification setting (and justification)
- Data review, trending and interpretation
- Gap analysis (especially for early phase)
- CMC Roadmap (especially for early phase)
- Audit preparation
- CRO/CDMO selection
- CMC strategy for IND/IMPD submissions
PM
- Project management to keep timelines, resources, and deliverables on track
Lab management
- Laboratory setup or expansion
- Optimization of operational processes