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REGULATOR-PROOF
YOUR STUDY |
| Early Phase Clinical Trial "MAXIMS" |
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Working closely with regulators is a key strategy for successful drug development, not a barrier to be sidestepped or overcome. Building regulatory advice into a trial program is an effective strategy to mitigate the regulatory risk inherent in product development and improve the likelihood of early product approval.
Requesting scientific advice from the right regulatory body at the right time has become an essential tool to guide product development and to have answer on many aspects of the development program:
- Have I chosen the correct and most appropriate animal model? And if there is no
pre-defined animal model, is my proposal appropriate?
- Is the manufacturing process well defined and appropriate?
- Have I well classified my IMP?
- Have I selected the appropriate comparator for my patient studies? Placebo/other treatment?
Are there financial incentives for small and medium-sized enterprises (SMEs) to seek scientific advice from the European Medicines Agency (EMA)? How does it work with the US Food and Drug Administration (FDA)?
To learn more about scientific advices from regulators with concrete case studies: |
For more information, contact us: clinicalresearch@sgs.com
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| DRUG DEVELOPMENT CONSULTANCY SOLUTIONS |
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Learn more about SGS Early Phase Drug Development Consultancy services. |
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| JOIN THE SCIENTIFIC COMMUNITY |
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Join the scientific community and connect with SGS on LinkedIn. Discover and share current R&D market news and events including bio/analytical laboratory and clinical research drug development information. |
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