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 that 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 authorization holders should have a functioning change control system in order to master the variation process and stay in compliance. For products registered via the Centralised procedure, the applications are made to EMA.
The use of change control software solutions can facilitate effective control of all post-registration changes to documents.
Achieving value-based pricing is a challenge to launch your product in Spain. QbD offers support to place your product on the market according to the Regulatory strategy and meeting national requirements, including Price & Reimbursement for inclusion in public financing.
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
- Serialization/ application for national codes
- Request pricing and reimbursement
Why QbD Group?
Benefit from our team of highly qualified consultants.
Full support from pre- to the post-marketing phase.
QbD Group operates on a global scale, with offices strategically located across Europe and South America. This extensive network allows us to efficiently execute projects in diverse locations worldwide.
Constant evaluation, transparency and clear objectives.
Contact us
Contact us for more information or to request a free, no-obligation proposal.
