National activities
Maintenance is very labour-intensive
The regulatory maintenance of medicinal products subsequent to marketing authorisation places enormous pressure on human resources. Depending on their specific product portfolios, companies report that they devote between 40 and 70% of their regulatory activities to product maintenance. In order to market safe and high-quality products companies are compelled to maintain their "subsidiary" portfolio, as well as their major revenue earners. By outsourcing your maintenance activities for established products you will be free to concentrate on important internal assignments.
Focus on key internal activities
Many companies have now recognised that the outsourcing of product maintenance to experienced service providers such as YES creates additional room for manoeuvre for their in-house teams, which are then free to concentrate on more forward-looking tasks.
Our services
All-round support for your marketing authorisations in the context of lifecycle management (incl. fulfilment of electronic requirements):
- Implementation of national stipulations
- Notification of variations
- Marketing authorisation renewals
- Process management
- Support right through to the completion stage
- Interfacing with the regulatory authorities
- Interfacing with your internal departments
- Management of graduated plan procedures (Stufenplan) and text modifications
- Manufacturing compliance management
What else do we have to offer?
We perform various additional activities, which may be of interest to your company:
- Complete maintenance services for mature/marginal products
- Maintenance of regulatory databases
- Compilation of basic information for promotional materials
- Evaluation of promotional materials in terms of their regulatory compliance
