The extensive and ever-changing regulations imposed by the FDA and other international pharmaceutical regulatory agencies almost guarantee that regulatory compliance will be a difficult task. Fortunately, many companies offer services specifically designed to streamline the approval of OTCs, Biologics, Medical Devices, Generics or New Drugs. Regulatory consultants can provide strategic planning, on-site monitoring and regulatory agency interaction. Many companies also perform audits to ascertain whether all pharmaceutical regulations are being met. They can also assist with regulatory submissions (e.g., IND, NDA, BLA, ANDA, IDE, PMA) or annual reports. Regulatory Medical Writing services are also available for reviewing or writing the packaging inserts, labels or advertising copy to ensure they follow all regulatory guidelines.
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