Lifecycle Management

Life Cycle Management (PLM) includes the entire lifecycle of a product – from its conception, through design and manufacture, to service and disposal.

QbD Group’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 can we support

Prepare variations

Ensure all required documentation is accurate and complete.

Submit to authorities

Efficiently manage and submit variation applications.

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 partner with QbD Group?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS

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, at QbD Austria with a special focus on Europe (EU) and China.
Customer satisfaction: constant evaluation, transparency and clear objectives.

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Need help managing your product’s lifecycle?

Get in touch with our experts for tailored support in handling variations, implementing change control systems, or navigating price and reimbursement processes.

Lifecycle Management

Reacting to changes

How we support you

Prepare variations

Prepare variations

Submit to authorities

Submit to authorities

Implement change control

Implement change control

Train your teams

Train your teams

Advise on software

Advise on software

Manage serialization

Manage serialization

Why partner with QbD Group?

Related content

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Regulatory Affairs for Pharma and Biotech

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IVDR extension: what does this mean for you?

Drug-Device Combination Products and Article 117

Mobile health on the rise: exploring the regulatory landscape for reimbursement

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CE Mark Renewal for bioXtra Products: A Success Story

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Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

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The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

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