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Sponsors of applications are also required to take a proactive approach, reviewing current literature and seeking out new information that may impact the labeling, promotion and safe use of their medical products. Global regulatory authorities, including the FDA, require holders of approved applications to have strict procedures and processes in place to receive these inquiries and complaints, to respond to them in an appropriate and timely manner, to track and trend them, to investigate possible problems, and to report this information to regulators on a timely and routine basis. An integral part of AAIPharma's Medical Affairs and Safety team, the Pharmacovigilance staff works closely with the Regulatory Affairs and Quality staffs and also offers support to clients not only post-approval, but also during drug development and clinical trials. In addition, services can be tailored to meet specific client needs with respect to medical information dissemination, quality complaints, adverse events, investigations, and tracking and trending of reports. Let AAIPharma help you with your pharmacovigilance needs. |
Conducting clinical trials and filing for approval is just the start of a medical product's life cycle. Once commercialized, countries worldwide have rigorous regulatory requirements that must be followed for manufacturing, testing, distributing and selling a new pharmaceutical. Included in these activities is continued pharmacovigilance to assess a medical product's safe and effective use. Physicians, pharmacists, nurses and other health care providers may have questions about how to use a product. Consumers may seek more information about a product. Complaints may raise a quality concern (broken tablets, leaking packages, discolored capsules, etc.), or the notification may be an adverse event associated with a new medical product, such as a possible interaction with another drug, an allergic reaction, or changes from the product safety profile observed during clinical trials.