Global pharmaceutical companies constantly need to design product labels for meeting regulatory compliance. This may be considered to be easier by some companies but what causes pain is the ongoing updates and maintenance of label changes.

Labeling services by MakroCare

  • Provides strategic and tactical labeling guidance to the cross-functional teams and affiliates
  • Development and approval of core labeling package (e.g. CDS, USPI, SmPC, others)
  • Update and maintenance of core labeling documents
  • Central (HQ) & local compliance
  • Management and approval of mock-ups and Label artwork
  • Labeling translation management
  • Local label creation & country specific QC

MakroCare Labeling department performs strategic & tactical services to Bio pharma companies. Based on your needs, we can do either of the below:

Labeling StrategyLabeling Operations
Development and approval of core labeling content (CDS, PIL etc.)Development and approval of packaging labeling text contents and mockups
Provides strategic and tactical guidance on labeling related issuesManage the labeling and artwork activities post HA approval, including launch actvities
Leads labeling negotiation with HAManage the specimens post each approval
Manage labeling response documentsResponsible for labeling documents technical formatting and submission readiness
Interact and ensure support from contributing line functionsDocument proofing/QC
Ensure core labeling is 'transletable' in the affiliatesTranslation. preparation and process
Organise PIL Readability testingMock-up for Readability testing

MakroCare has in depth experience in Medical Services & Regulatory Affairs. Our experts are connected to deliver integrated solutions globally with detailed knowledge of different local guidelines. Through our shared resources and management techniques, we can offer innovative value-added solutions that augment your internal teams / processes.

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