Deloitte’s data remediation tooling efficiently creates structured data from (unstructured) information. Using artificial intelligence powered technology, we can extract all relevant data elements from your regulatory documents. Our IDMP offering of data remediation as a service is designed with a 4-step approach including extraction of the data elements, remediation to align the data with IDMP standards and verification performed by IDMP SMEs. The output is aggregated in the format you require to import into your RIMS.

Achieving a high level of data quality and trustworthiness for your (regulatory) product information is essential for any organisation. It requires subject matter expertise, experience and knowledge. Our team can assist you with incorporating the latest data requirements (e.g. PLM, ISO IDMP, PQ-CMC, TOM). We provide dedicated resources with the right capabilities and knowledge to enable you to focus on strategy, development, innovation, while we guarantee data quality.

As part of our service, we re-engineer your data management processes to improve efficiency and maximise effectiveness, while simultaneously increasing the quality of your data.

We supply regulatory data services that keep you in control and in compliance of your products, in combination with our consultancy services.

Our team can support you with the management of:

• RIM
• XEVMPD
• PLM
• SPOR
• ISO IDMP
   

Authoring and maintaining the label documentation for a medicinal product is one of the most important elements of the authorisation processes. Getting this right is critical to maintain compliance and to ensure that patients and healthcare providers always have the latest information at hand.
The combination of Deloitte’s advisory expertise paired with the Operate team’s provision of Labeling as a Service sets our clients up for success.

Our experts will work in collaboration with your teams to establish a clear label management process; label and data quality control, proofreading (etc) that fits with your established business model and existing technical solutions, supported by our data experts for label management.

Our team can support you with:

• Technical authoring
• Document migration
• Document Quality Control and proof reading