---
title: "Clinical Regulatory Services — Clinical Solutions | QbD Group"
description: "Handling the complexities of clinical investigation approvals can be daunting. We streamline the process, ensuring you get the green light to start your st"
url: https://qbdgroup.com/en/services/clinical-solutions/clinical-regulatory-services
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Clinical Regulatory Services — Clinical Solutions | QbD Group\", https://qbdgroup.com/en/services/clinical-solutions/clinical-regulatory-services"
---

# Clinical Regulatory Services

Streamlining clinical investigation approvals

Handling the complexities of clinical investigation approvals can be daunting. We 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 encompass 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 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.

### Identifying study type

Identifying the type of study and involved authorities.

### Ensuring compliance

Ensuring compliance with all relevant regulations.

### Country-specific submission

Managing country-specific submission processes.

### Avoiding delays

Avoiding delays by preparing complete and accurate submission packages.

### Gaining approval

Gaining approval for both applications and modifications or reports during the study’s lifecycle.

## How can QbD Group support you?

We provide tailored support to sponsors and manufacturers, from small startups to large medical device companies.

### 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, IFUs, GSPR checklists.

### 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.

### Ongoing support

Amendments, modifications, and reporting throughout the study until the final study report is complete.

Why QbD Group

## Your trusted partner

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

Strategic insight: we help you with your submission strategy that aligns with realistic timelines.

Regulatory expertise: we ensure your submissions are complete, accurate, and adhere to necessary regulations.

Hands-on support: from initial submission to responses to authorities’ requests, we handle every detail.

FAQ

## Frequently Asked Questions

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## Plan your clinical pathway

From gap assessment to full CRO delivery, our clinical experts are ready to support your MedTech journey.

Contact us

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Source: https://qbdgroup.com/en/services/clinical-solutions/clinical-regulatory-services — © QbD Group. Quote freely with attribution and a link back.