PIM for EMA

PIM was introduced by the EMA to help increase the efficiency of the management and exchange of product information (PI) by structuring the information and exchanging it electronically. It aims to improve the quality and consistency of the published product information.

The EMA have reported that “the average number of product information documents associated with a single Trade Name is between 650 and 1,000 documents. It is not unusual to have more than 1,500 documents”. PIM will make managing this information a lot easier.

Our PIM development programme has included two pilot legacy migration projects and we have developed robust practices and procedures that enable us to provide a high quality PIM service.

Our regulatory publishing consultants can assist clients with:

• Full migration of legacy product information in Microsoft Word format to multilingual PIM XML
• Complete translation of new ‘Day 0’ PIM submissions with our carefully selected translation partner

If you require any assistance with regulatory submissions from our eSubmission specialists, please contact us, at no obligation.