Pharmaceutical Labeling Services

Our new associate that covers Pharmaceutical Labeling and Product Packaging Design or Pharmaceuticals builds on our existing expertise in Herbal products.

Labelling: EU

 

IDA Consultants is highly experienced in developing and reviewing all labelling documentation for EU markets, in full accordance with EU legislation. This includes core data sheets, Summary of Product Characteristics, Patient Information Leaflets, inner and outer package labels, Braille requirements and barcoding practices. Throughout our international network of translators and in-country specialists, we can also provide labelling documentation in all EU languages. GRC has an intimate knowledge of EU regulatory requirements for the submission of medicinal products

 

Other Related Services

 

Full labelling documentation review (from SPC to outer package labelling)

Translation: based on up-to-date ISO and EN standards.

 

Developing labelling documentation.

 

IDA  has long-standing expertise in the area of developing labelling information, particularly the copywriting, design and readability testing of Patient Information Leaflets. Mark Gibson was one of the first people in Europe to begin readability testing of PILs commercially and has a sound understanding of EU Competent Authorities’ varying regulations.

 

Related Services

 

SPC Harmonisation:

Patient Information Leaflet copywriting:

Development of patient education materials, e.g. to support a Risk Management Plan

Readability testing

Readability testing, in language other than English

Readability testing / consumer evaluation of medication guides in North America