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NEW QUESTION: 1
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?
A. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
B. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
C. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
Answer: B

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