Life cycle management
Life Cycle Management (PLM) includes the entire lifecycle of a product – from its conception, through design and manufacture, to service and disposal.
QbD’s experts accompany you throughout the whole process.
Reacting to changes
Products which have been put on the market change over time and this process must be managed, as it moves through its succession of stages.
In the pharmaceutical industry clear guidance is given on types of variations and dossier requirements (Regulations (EC) No 1084/2003 and (EC) No 1085/2003).
For products registered via MRP or DCP any variations must be submitted simultaneously to the competent authorities in the Member States where the product is on the market. Marketing authorisation holders should have a functioning change control system in order to master the variation process and stay in compliance.
The use of change control software solutions can facilitate effective control of all post-registration changes to documents.
How we support you
- Prepare variation packages
- Submit variation to competent authorities
- Set up a functioning change control system in your company, including writing and implementing appropriate SOPs
- Train your professionals
- Advise on appropriate software
Why opt for the QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
10+ years of experience
Benefit from our team of highly qualified consultants.
Full life cycle support
Full support from pre- to the post-marketing phase.
Global presence
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.
Customer satisfaction
Constant evaluation, transparency and clear objectives.
Contact us
Talk to an expert
Contact us for more information or to request a free, no-obligation proposal.