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SAILING INTO THE WIND
REGULATORY AFFAIRS
CurAccel’s Regulatory Affairs services provide a comprehensive and complete regulatory strategy in a progressively regulated industry. Our services focus on experience and expediency to accelerate the regulatory processes.
CurAccel can operate as a functional service provider or as a standalone provider. At a minimum, our Regulatory Affairs offerings are:
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Strategic planning and oversight of all regulatory activities
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Coordinating of central ethics committee submission and approval
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Advise on labeling of IMPs
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Compiling IMPDs
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Preparing and filing clinical trial applications
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Translation services
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Obtain import/export licenses
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Legal representative services in the EU
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