Management of artwork updates and review processes

PLG can provide clients with end-to-end labeling management support. Our team has extensive expertise in managing global and regional drug labeling and in using enterprise-resource-planning systems such as SAP to support the artwork review process.

Package inserts and labels often represent the primary means of communicating safety information to health-care professionals and patients. They also form the basis for the development of promotional labeling materials. Therefore, product labeling should provide all of the information necessary for a product’s safe and effective use as indicated. Our team has extensive expertise in managing global and regional drug labeling and in using enterprise-resource-planning systems such as SAP to support the artwork review process. In addition, our team can support the following activities by using either a client’s own regulatory affairs resources or PLG’s experienced regulatory affairs team.

  • Labeling review and compliance
  • Preparation of label comparisons for submission to health authorities
  • Label-content-change control management, supported by such tools as SAP or TrackWise
  • Local label safety alignment with reference label
  • End-to-end global and regional labeling management
  • Artwork change initiation
  • Artwork review against local regulatory requirements, supported by proofreading by Text Verification Tool software
  • Artwork-change approval

Readability user test management

Companies are encouraged to seek advice from specialists in information design when devising their in-house styles for package leaflets so as to ensure that design and content are easy to navigate and understand. PLG can help clients with readability user testing of package inserts in any language.

Package leaflets are intended for patients and users. If a package leaflet is well designed and clearly worded, the information in it can be understood by a majority of people, including older children and adolescents, people with poor literacy skills, and people with some degree of sight loss. Companies are encouraged to seek advice from specialists in information design when devising their in-house styles for package leaflets so as to ensure that design and content are easy to navigate and understand. PLG can support clients by means of the following steps.

Coordination of Readability User Testing:

  • Establishing assumptions and advice about readability tests and/or bridging
  • Providing questionnaires for the testing
  • Selecting participants and interviewing them
  • Delivering a draft and a final report

Translation coordination for labeling materials

Medical translation requires precision and up-to-date technical knowledge. PLG’s translation and proofreading service is performed by experienced translators at our translation partner.

Language translations are required at many stages in the course of bringing a drug to market, including the stages of clinical trials, regulatory submissions, manufacturing, packaging, and marketing. The translation requirement has a surprisingly major effect—for better and for worse—on several crucial factors: the total cost of trials, time to market, the possibility of recalls or rejections by regulators, and even the safety and efficacy of the marketed product. Therefore, medical translation requires precision and up-to-date technical knowledge. PLG’s translation and proofreading service is performed by experienced translators at our translation partner. The types of documents we translate for our clients include:

  • Marketing Authorisation Application dossiers
  • Package labels and inserts
  • Regulatory documents
  • Health agency communications

1,500

Approximate number of artwork updates per client per year