Emerging Markets

Product maintenance

The regulatory maintenance of medicinal products subsequent to marketing authorisation places enormous pressure on human resources. Depending on their product portfolio and the complexity of the national requirements, companies report that they devote between 40 and 70% of their regulatory activities to maintenance tasks. In order to market safe and high-quality medicinal products companies are compelled to maintain their "subsidiary" portfolio as well as their major revenue earners. In the Emerging Markets the ongoing dossier maintenance efforts are disproportionately high relative to the potential sales revenues.

By outsourcing your maintenance activities for Emerging Markets your core staff will be free to concentrate on regulatory activities for major revenue earners in established markets.

Focus on central products and markets

In accordance with your specific requirements YES will perform maintenance activities

• for individual Emerging Markets

In this way you will benefit from our specific experience in these countries.

• for predefined products in several different markets

In this way you will profit internationally from our detailed knowledge of your products.

Our services:

All-round support for your marketing authorisations in the context of lifecycle management:

• Implementation of national stipulations
• Variations
• Evaluation of manufacturing compliance
• Marketing authorisation renewals
• Process management
• Support right through to the completion stage
• Interfacing with the competent regulatory authorities
• Interfacing with your internal departments