Regulatory labelling – supporting clients from creation to maintenance

Labelling regulations are essential for ensuring products are used safely and appropriately by patients. However, labelling compliance requirements can differ across regions and new regulations are regularly being introduced. Prescription drug labelling includes a wealth of information about a product, often many pages long and including text and tables. Guidances are issued for each different aspect of labelling, such as clinical labelling, dosage and administration, warnings and precautions, adverse reactions and so on. This makes global and regional labelling management a complex and time-consuming activity for life sciences companies.

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.

Our highly skilled labelling professionals provide a labelling assessment to determine your needs and to help you understand labelling regulations. We can tackle complex tasks, such as creating, updating and maintaining the Company Core Data Sheet (CCDS) and support you with all product marketing labelling.

Celegence offers high-level expertise in:

  • Labelling strategy and preparation
  • Compliance analysis and review
  • Legacy product support, spanning global labelling management and regional labelling management
  • Knowledge of all current global and regional labelling requirements

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

Request Information
close slider