Digital Consultancy

In the pharmaceutical industry, document and data integrity plays a vital role during development and in maintaining the quality and safety of products once they are in use.

Having control of data, especially in an era of advancing technology, remains one of the key requirements and challenges in our discipline.

Data quality and integrity requirements have been defined by standards organisations and regulators in numerous guidance documents.

In Billev Pharma East, we have a hands-on approach to help our clients to manage their data in the most efficient way. 

Together with our partners, we can provide a comprehensive set of services related to data and document management:

• Analysis of your current IT landscape
• Advise on implementation of new IT systems, including RIM and Document management systems
• Regulatory data identification (from documents to organised data)
• Data migration
• IT validation (EU-GMP Annex 11, FDA 21CFR Part 11)
• IT audits
• Preparation and publishing of electronic submissions in eCTD, NeeS and VNees format
• Practical advice on IDMP scope and implementation
• Handling and submissions of XEVPRM data
• Handling and submissions of ICSR and pharmacovigilance data