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Grünenthal Innovation is a fully integrated, capable and agile R&D organization. Through our networked approach, we interlink and supplement our R&D expertise with external knowledge.
Our in-house expertise includes, but is not limited to:
Drug Discovery: linking target to disease to create innovation
- Selection and identification of validated targets based on niche disease strategy and portfolio fit
- Creation of relevant biological screening cascades and rapid testing cycles
- Proficient in multidimensional optimization strategies to deliver target modality or technology
Focused pre-clinical development – bringing new therapeutic options safely to patients
- Support of candidate selection and optimization of modalities
- Specialized pharmacology offering a unique platform of respective models in order to select and profile molecules in pain/pain sub-indications and focused indications
- Delivery of robust pre-clinical data package
- Support of clinical development
Strategic translational science – building the bridge to humans
- Innovative in vitro / in vivo models and biomarkers
- Novel biomarkers and pharmacodynamic models in healthy volunteers
- Innovative pharmacology and proof of concept clinical trial design, including outcome measures
Solution-focused clinical development
- Holistic clinical trial strategy and planning
- Full clinical trial operations
- Experienced CRO management
- Best-in-class data management, data analysis and modeling and simulation
CMC – bringing compounds to life
- Capabilities to develop sophisticated formulations for pre-clinical and first-in-human trials
- Full analytical development services for drug development
- Capabilities to develop cutting edge formulations for our patients, e.g., capsules, liquid solutions, patches, or suppositories
- Fast upscaling to serve large, worldwide clinical trials and initial market entries while maintaining the highest quality standards
- Own engineering capabilities for development of customized equipment beyond standard technologies.
Regulatory Affairs – adding value from the beginning
- Excellent reputation with regulatory authorities in EU and beyond
- At forefront of new regulatory trends to shape and prepare for new standards
- Global capabilities and network to ensure worldwide marketing authorizations and their mainenance
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