Regulatory Intelligence

Understanding the complex landscape of regulations and standards in the world of medical devices, IVDs and pharmaceuticals can be challenging. Keeping up-to-date with the ever-changing requirements not only protects your business but also drives operational success and innovation.

At QbD Group, our expert consultants provide comprehensive regulatory intelligence, ensuring that you stay informed and compliant with the latest updates. This allows you to focus on innovation and excellence in your field.

What we offer

PURSUE AN INTELLIGENT STRATEGY

Regulatory intelligence is essential for successful device development and regulatory strategy. By leveraging up-to-date and comprehensive information, you can not only stay ahead of the competition but also ensure that your products are in full compliance with the current and ever-evolving regulations. This proactive approach helps in identifying potential regulatory hurdles early in the development process, allowing for strategic planning and risk mitigation.

Regulatory Intelligence may include:

Regulatory information
Competitor Information
Information on Legal Requirements
Legislation updates

How can we support

Regulatory information

We monitor and analyze regulatory updates, ensuring you receive timely insights into changes that affect your device development.

Determining legal requirements

Our experts help interpret complex regulations, guiding you in aligning with all applicable legal standards for your medical devices.

Tailored legislative support

We advise on specific legislation updates and ensure you stay ahead of any changes to maintain a competitive edge.

Managing standards evolution

We keep track of new and obsolete standards, helping you adapt seamlessly to the latest requirements.

Comprehensive information packages

Our detailed information packages offer a thorough analysis of any regulatory query, empowering you to make informed decisions.

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.