DDReg Pharma

Product Labelling

Product labelling is intended to accurately communicate product information to healthcare professionals and consumers. If a product is incorrectly labeled, or is subjected to errors, it can pose risk in several domains including non-compliance, patient/consumer safety, and product recalls that could be a cost burden for manufacturers. Therefore, it is crucial for pharmaceutical companies to work along regulatory compliance when developing pharma labels for products.

DDReg understands the necessities for appropriate regional and global labeling. We offer extensive Regulatory Labeling services for labelling management, whether globally or region-specific. Additionally, we assist with the authoring of investigational brochures and company core data sheets. Our highly experienced and dedicated team monitors changes and regularly updates the data sheets for various regions whilst ensuring clinical overview guidelines are complied with when submitting a request for review from Health Authorities. We facilitate cross-functional labelling alignment across all operational and functional areas to incorporate knowledge. We also assist in drafting, formatting, and maintaining Clinical and Medical documentation including submission of Labeling Variations, according to ICH and region-specific requirements.
DDReg ensures first-time quality and compliance across all labeling domains including clinical, global and regional. We produce on-time labeling packages that meet all labeling needs.

DDReg’s Product Labeling services include:

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