One could believe, that after the marketing authorization procedure the Regulatory work is done, but once approved life-cycle starts. 
The reasons for changing to the terms of a marketing authorization are manifold: from implementing minor changes to your manufacturing procedure until those having a higher impact on the product's quality, safety or efficacy. Each change must be evaluated, categorized and potentially notified to or approved by health authorities. 
I provide you with a successfull life-cycle management with the experience to manage changes as the product moves through its economic life.