Life-Cycle Maintenance

Services

Prolong the competitiveness and profitability

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.

Services

 
  • Strategic planning
  • Classification of variations
  • Preparation of documents relevant for variations
  • Coordination of the variation procedure
  • Closing