Global pharmaceutical companies constantly need to design product labels for meeting regulatory compliance.
Core services that MakroCare offers are:
- Provides strategic and tactical labeling guidance to the cross-functional teams and affiliates
- Development and approval of NEW core labeling content (e.g. CDS, CSI, BPL others) documents
- Update and maintenance of core labeling documents
- Central & local harmonization
- Management and approval of mock-ups and artwork
- Management of labeling translations
- Global tracking the implementation of label changes
- Monitor and ensure world wide labeling compliance
MakroCare Labeling department offers strategic & tactical services to Bio pharma companies. Based on your needs,we can do either of the below:
MakroCare has in depth experience in Medical Services & Regulatory Affairs. Our team of dedicated professionals have strong industry and agency experience who can tailor project plans to meet different regulatory requirements.
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 services.