Labeling seems simple to all stake holders who are not involved with Labeling. The development, maintenance, and implementation of pharmaceutical labeling is complex.
Multiple inputs and/or reviews needed by different business units – Labeling department, Pharmacovigilance, Clinical Research, Medical, Regulatory Affairs, Sales & Marketing, Manufacturing, and last but not least, Legal. Core activity is not complex, but because of high degree of interaction between cross-functional teams result in too many handoffs and coordination overload.
Adding to the complexity, if company is global, responsibilities alignment and/or division between HQ and local affiliates will also become a major factor. Even if properly aligned, because of staffing issues of local affiliates keeps this a highly “coordinated” process in companies.
Minimizing hand-offs is a quicker and better way to improve efficiency in the Labeling process. Applying LEAN or Six Sigma methodologies can lead to even more reduction of unnecessary or redundant steps.
As an example, to implement this in a phased manner, it’s advisable to ideally pick low-complex work like Art Work centralization or medical content development in first phase. Later, add first level of Medical and Regulatory review steps by 1 team or 1 vendor to reduce the load on HQ teams before their review.
Does Labeling belong to Regulatory Affairs or Safety business units ? Every company has a different opinion on this. Planning and review should be managed by these departments but implementation can be with 1 team or 1 vendor irrespective of whether it’s Regulatory Safety documents to take advantage of “common” knowledge. But companies should see the inherent embedded value on reusability and aim to reduce duplication by partnering beyond silos.
MakroCare can help with “fewer hand-offs” and “decreased duplication”. Whether it’s US/EU/ROW Labeling, MR Reviews, Medical inputs, or Global Art Work, MakroCare can bring an integrated view to attain process efficiency. We can also maintain/manage core data labeling documents updation and maintain global consistency by coordination with local affiliates to ensure all labeling is in sync.
If you are thinking to strategize global labeling or improve labeling efficiency, please contact us at firstname.lastname@example.org
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