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Global Labelling and Ad Promotion

Flexible, end-to-end labelling and advertising promotion for global product development

ICON global labelling and ad promotion supports all stages of product development, maintenance and operations. 

Our team of experts understand the philosophy of core labelling and global labelling regulations. We develop customised strategies to ensure full compliance with all local and regional requirements and provide skilled resources with deep domain knowledge across labelling strategy, labelling operations, intelligence, compliance, translation, artwork, ad promotion and consulting services. Our end-to-end lifecycle management ensures alignment with your business objectives under a flexible service model to meet your changing operational needs. 

Key services

  • Strategic consulting and operational execution of labelling core services and/ or across service lines
  • Global labelling content development and label review/ maintenance across drug and medical devices
  • Labelling strategy services, including TPL (template files), core and clinical labelling support​
  • Labelling authored documents, including Microsoft Word formatting and template design​
  • Structure product content services including structured product labelling/ structured product monograph
  • Labelling translation services for global markets
  • Artwork and packaging design and maintenance​
  • Labelling compliance services - tracking, metrics and audit support​
  • Global ad promotion services​ for review and control of promotional materials
  • Regulatory labelling intelligence​

End-to-end expertise

Our global labelling and ad promotion team is comprised of skilled regulatory labelling experts with a wealth of experience throughout product development and post-marketing environments. Our subject matter expertise covers all product types (small molecules, biologics, sterile products) and dosage forms and includes drugs, devices and drug-device combination products. With this depth of knowledge, we can identify potential risks, develop mitigation strategies and provide resolution to labelling challenges to optimise lifecycle management.

Complete product life cycle management

Pre-clinicalClinicalMarketing authorisationLife cycle maintenance
Provide strategic labelling input for clinical trial design and development of target product labellingProvide regulatory
expertise to drug
development teams on the development and submission of target labelling and proposed labelling for regulatory agency approval		Lead global/ regional working groups in the development, review and approval of core and major regional labellingCreate, manage and update labelling content to ensure client objectives are met
Support Investigational Brochure, Risk Management and Study Protocol developmentSupport the initial work on a development core data sheet (dCDS) & development core safety information (dCSI)Support packaging creations e.g. layout, mock-ups, production artworkMonitor regulatory intelligence for updates impacting labelling
Provide guidance on device labelling development Support device and combination product labellingEstablish global tracking and compliance processes/ programs evaluate for trends, participate in audits/ inspections
Monitoring health authority websites and other sites for industry updates related to product labelling Manage translations and linguistic review processEnsure change control processes are followed to maintain accuracy of change during versioning of documents
Provide information on competitor labelling to support labelling development Manage labelling ad promo reviewMonitor progress, identify risks and propose solutions/ improvements

 

 

 

 

Coordinate labelling submission, approval and implementation activities

 

 

The ICON offering

 

Labelling strategy

  • Provide regulatory expertise on required labelling updates and subsequent submissions of labelling components for approval
  • Proactive reviews to identify potential non-compliance. 

Labelling operations

  • Provide technical review and quality control of labelling documents to align with regulatory guidance and local requirements.
  • Create, manage and update labelling content based on regulatory guidance 
  • Provide technical review and quality control of labelling documents
  • Monitor regulatory intelligence for updates that may impact your labelling

Compliance and metrics

  • Develop and implement tracking and compliance processes
  • Write and track corrective and preventive actions and support preparation for audits and inspections

Ad promotion

  • Provide Advertising and Promotion services
  • Ensure compliance and control of promotional documentation
  • Participate in strategic planning meetings to support discussion and provide guidance
  • Support the development and review of standard text and templates related to ad promotion materials
  • Ensure change control processes are followed to maintain accuracy of change during versioning of documents

 Consulting services 

  • Optimise current operating models and prepare for future labelling requirements 
  • Provide labelling process consulting services to establish end-to-end processes, to improve internal governance and/or to streamline existing processes
  • Identify potential challenges, offer training programs, build customised labelling management frameworks, develop processes and SOPs, offer training programs, monitor regulatory labelling intelligence and inform operational efficiencies
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