Regulatory labelling – supporting client requirements from creation to maintenance of global and local drug product labelling

Labelling regulations are essential for ensuring compliance of drug products to be used safely and efficaciously by patients. However, labelling compliance requirements can differ across regions and new regulations are regularly being introduced to update labelling documents. Prescription drug labelling includes the core safety and clinical information about a drug product, often in the form of a local regional label for example Summaries of Product Characteristics (SmPC); United States Production Information (USPI) or Product Monograph (PM); or, expressed as a global company core document such as Company Core Data Sheet (CCDS).  Guidance, mandates and recommendations are issued for each different aspect of labelling, such as clinical labelling, dosage and administration, warnings and precautions, adverse reactions and general guidance with respect to therapeutic group classes. This makes global and regional labelling management a complex and time-consuming activity for life sciences companies to ensure consistency and compliance across the concerned regions.  Our team can help ensure that the most up to date information is expressed in the labelling documentation to patients and healthcare practitioners.

Celegence – proven labelling expertise

Celegence provides end-to-end labelling services to help life sciences companies build and maintain labelling information, including safety and efficacy information on country-specific labels to enable compliance and due diligence in their labelling for their drug product portfolio.

Our highly skilled labelling Subject Matter Experts (SME) provide initial labelling assessment to determine your needs and to help you understand labelling regulations. Our panel of experts can tackle complex tasks, such as creating, updating and maintenance of the Company Core Data Sheet (CCDS). We can provide guidance on the regional specific regulation changes for example the (Pregnancy Lactation Labelling Rule) for the US FDA; the Falsified Medicines Directive that affects all EU markets to incorporate track and trace serialization coding on outer-packages, as well as the BREXIT impact analysis that will impact labelling as well as artworks.  Furthermore, updating local-regional labels and provide support in all aspects of drug product market labelling.

Celegence offers high-level expertise in:

  • Labelling strategy and preparation
  • Compliance analysis and review of labelling documents
  • Legacy product support, spanning global labelling management and regional labelling management
  • Knowledge of all current global and regional labelling requirements
  • Creation of new Global CCDS and Local labeling management in terms of HQ, Local affiliate activities and streamline / harmonization of labeling activities which includes lifecycle management of CCDS, Artwork, Labeling variations
  • Assistance in creation of background Medical and Clinical documentation that includes Writing, Formatting, Publishing and Submission of Labeling Variations to local authorities using ICH and country specific requirements, to aid the submission of local update labels for Health Authority submissions
  • Experience in handling cross-functional multidisciplinary stakeholders to ensure labelling alignment across all functional areas and experts
  • Ensure first time quality and compliance in all aspect of labelling with detailed packages delivered in a timely manner

Learn more about our niche service offerings:

MEDICAL WRITING

Medical writing – delivering specialty knowledge

MEDICAL DEVICES

Medical devices – addressing a changing regulatory environment

PUBLISHING AND ECTD SERVICES

Publishing and eCTD services – tackling global submission challenges

REGULATORY OPERATIONS MANAGEMENT

Managed regulatory operations related to publishing, submission and regulatory information management for reduced total cost of ownership

IDMP & COMPLIANCE CONSULTING

Organizational readiness assessment for IDMP, xEVMPD and UDI compliance and support activities like data collection, maintenance, submission and governance

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