The impact of the ISO IDMP requirements challenges pharmaceutical companies when it comes to finding and locating their data for future ISO IDMP submission. Pharmaceutical companies that are either sponsors of trials or marketing authorization holders for commercial products are required to submit ISO IDMP-formatted data to EMA following the phased approach. In order to become ISO IDMP compliant, companies that have outsourced manufacturing processes to external suppliers, for instance to Contract Manufacturing Organizations (CMO) or to Contract Research Manufactures (CRO), need to retrieve their data. This constitutes a significant challenge for many companies and raises a series of questions: Are your external suppliers ready to send you ISO IDMP data? Do they know about ISO IDMP? Are their data compliant to the ISO IDMP required formats? Which of your external suppliers are required to send ISO IDMP data to you? NNIT can help you establish an overview by conducting an ISO IDMP Supplier assessment.
NNIT works with clients to locate and capture ISO IDMP data from external suppliers. We help identify the relevant suppliers, which data you should retrieve, and in which formats. NNIT’s ISO IDMP supplier assessment enables you to: •
Your organization is obliged to comply with ISO IDMP. Noncompliance may result in penalties of up to five percent of total revenue. NNIT’s ISO IDMP supplier assessment ensures that no external supplier is left out, and no ISO IDMP data is neglected the day you submit your supplier data to the EMA. Furthermore, the assessment will ensure that suppliers hereafter deliver ISO IDMP data in the proper formats. The ISO IDMP Supplier Assessment is conducted by subject matter experts with a profound domain knowledge and insight into ISO IDMP. The ISO IDMP supplier assessment is recommended for pharmaceutical companies that are required to submit ISO IDMP data to EMA and companies that sell medicinal products or conduct trials in the EU or EEA.