Life Sciences: Advertising and Promotional Compliance

A large bio-tech firm based in the US was struggling to capture its approvals of promotional materials. As regulations tightened around requirements to show not only approvals, but also the versions and the comments that led to the final approved artwork, XL-Lead Consulting was brought in to meet the challenge.

XL-Lead consultants reviewed various regulatory requirements and conducted industry profiling to short-list three vendors that could meet the client’s needs. Based on a rigorous evaluation technique, one vendor was selected to move into execution. Key criteria that the vendor met included utilizing PDF functionality for approvals and comments; system should be web-based and cloud hosted; retrieval of versions and approvals should be intuitive; system should generated FDA form 2253.

System was implemented in record time: 3 months. Aggressive timelines were set early due to a lack of budgetary allocation at the end of the current quarter. Deadliness were met, and system was rolled out and adopted worldwide.

Success was attributed to collaboration between XL-Lead Project Management Consultants, key business users, and solution provider. XL-Lead Consultants also travelled to regional sites to ensure training and adoption of system.