Lifecycle Management
Managing changes throughout the product lifecycle
Products that have been put on the market change over time and this process must be managed. QbD Group's experts accompany you throughout the whole lifecycle management 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
Adapting to regulatory changes can be complex. At QbD Group, we provide tailored solutions to ensure your submissions meet the highest standards.
Prepare variations
Ensure all required documentation is accurate and complete for variation submissions.
Submit to authorities
Efficiently manage and submit variation applications to competent authorities.
Implement change control
Establish and maintain a robust system for tracking and managing changes.
Train your teams
Provide hands-on training for your professionals on regulatory processes.
Advise on software
Recommend and implement the right tools for managing regulatory tasks.
Manage serialization
Handle national codes and serialization requirements seamlessly.
Why QbD Group
Your trusted partner
Choosing QbD Group means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.
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 Group operates globally, with QbD Austria having a special focus on Europe (EU) and China.
Customer satisfaction: constant evaluation, transparency and clear objectives.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.