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Clinical Trial Activation and Maintenance |
- Preparation, submission and maintenance of INDs, CTAs, IMPDs and IBs (responsibility as surrogate for client or under Transfer of Obligation)
- Liaison with regulatory agencies
- Obtain import licenses/export permits
- Clinical supplies label prep and/or review
- Protocol and IB review
- Facilitation of IRB/ethics committee submission and approval
- Review labeling of clinical trial material
- Investigational Drug Product release and shipment
- Review protocol packages
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Contact us to speak with our Regulatory experts |
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