SAILING INTO THE WIND

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REGULATORY AFFAIRS

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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.

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CurAccel can operate as a functional service provider or on a standalone basis.  At a minimum, our Regulatory Affairs offerings are:

• Strategic planning and oversight of all regulatory activities

• Coordinating of central ethics committee submission and approval

• Advise on labeling of IMPs

• Compiling IMPDs

• Preparing and filing clinical trial applications

• Translation services

• Obtain import/export licenses

• Legal representative services in the EU