Clinical Regulatory Services

Handling the complexities of clinical investigation approvals can be daunting. Without the necessary expertise, your study may face unnecessary delays or roadblocks.

But that's why we’re here to streamline the process, ensuring you get the green light to start your study efficiently and in full compliance.

What are clinical regulatory services?

Clinical regulatory services encompasses all the approvals and submissions required to initiate and maintain a clinical investigation.

This includes submissions to competent authorities, ethics committees, and other national bodies that are applicable to your study.

Country-specific knowledge is essential to prepare a good submission package and optimize the review process. Compliance with regulations and guidelines such as MDR, GCP, ISO14155, GDPR, and national legislation is crucial for both approval and the successful conduct of your study.

Why is it important?

Under the MDR, stricter requirements and tighter timelines make it crucial to have a thorough understanding of both European and country-specific regulations.

To be able to perform your study in Europe (or beyond), you need to have appropriate authority and/or ethics approvals in place.

An experienced partner is invaluable for:

Identifying the type of study and involved authorities.
Ensuring compliance with all relevant regulations.
Managing country-specific submission processes.
Avoiding delays by preparing complete and accurate submission packages.
Gaining approval for both applications and modifications or reports during the study’s lifecycle.

Discover how we can help

Submission strategy

Guidance on the best submission route and strategy to align with your goals and timelines.

Submission requirements

Clear documentation of what’s needed, including templates and document support.

Submission preparation

Compilation of complete submission packages, including essential documents like cover letters, powers of attorney, IFUs, GSPR checklists, site suitability, etc.

Submission execution

Direct handling of submissions, including expertise in country-specific portals and processes.

Approval follow-up

Follow-up until approval, assistance with responding to requests for information coming from authorities or ethics committees.

Ongoing support

Amendments, modifications, and reporting throughout the study until the final study report is complete. We also cover other involved bodies that require submission or notification.

Why partner with QbD Group?

Our service supports the entire study, from initial approval through reporting and modification submissions, all the way to the final study report.

Here’s how we make the difference:

Strategic insight: we help you with your submission strategy that aligns with realistic timelines and regulatory expectations.
Regulatory expertise: we ensure your submissions are complete, accurate, and adhere to the necessary regulations for approval.
Hands-on support: from initial submission to responses to authorities’ requests, we handle every detail, ensuring your study moves forward without delay.

Which countries have fast approval processes?

The approval timelines vary by country and depend on factors like regulatory pathway, required documentation, fees, and contract processes. We use our country-specific knowledge to advise on the best approach based on your priorities, such as fast review times or low regulatory burden.

What documents are needed for submission?

The core requirements are listed in MDR Annex XV Chapter II, but country-specific documents may be needed. These can include cover letters, power of attorney, GSPR checklist, site suitability forms, and more. Our team ensures all required documents are included and tailored to the specific country and study type.

Resources

Case study

Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Discover all

Clinical Regulatory Services

What are clinical regulatory services?

Why is it important?

How can QbD Group support you?

Submission strategy

Submission strategy

Submission requirements

Submission requirements

Submission preparation

Submission preparation

Submission execution

Submission execution

Approval follow-up

Approval follow-up

Ongoing support

Ongoing support

Why partner with QbD Group?

Which countries have fast approval processes?

What documents are needed for submission?

Get in touch

Resources

Fast-Tracked Site Qualification for Clinical Trial Submission

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

Clinical investigations under MDR: key insights and practical experiences

The pathway from idea to patient under MDR

CE Mark Renewal for bioXtra Products: A Success Story

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter