---
title: "Scientific Advice — Regulatory Affairs | QbD Group"
description: "Scientific advice procedures play a central role in the drug approval process. Our experienced consultants help you interact with all relevant health autho"
url: https://qbdgroup.com/en/services/regulatory-affairs/scientific-advice
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Scientific Advice — Regulatory Affairs | QbD Group\", https://qbdgroup.com/en/services/regulatory-affairs/scientific-advice"
---

# Scientific Advice

Expert guidance for regulatory authority interactions

Scientific advice procedures play a central role in the drug approval process. Our experienced consultants help you interact with all relevant health authorities.

## Types of scientific advice

An essential step in the early stages of developing a potential medicinal product is the preparation of the Clinical Trial Application for the First in Human (FIH) clinical trial.

QbD Group's experts will guide you through this process and subsequent steps, for example ensuring compliance with EU Pediatric Regulation Requirements, leveraging opportunities for Orphan Drug Status, and actively seeking regulatory authority input through Scientific Advice procedures throughout the development journey.

## How we support you

We offer a range of specialized services to support your interactions with regulatory authorities.

### Initiate authority contact

We assist in establishing initial contact with regulatory authorities, ensuring clear communication.

### Prepare briefing packages

Our team prepares comprehensive briefing packages to support regulatory submissions.

### Moderate authority meetings

We efficiently manage and moderate meetings with regulatory authorities.

### Dossier (CMC) guidance

We provide expert guidance on Chemistry, Manufacturing, and Controls (CMC) dossiers.

## What does it entail?

**Agency interactions** — Successfully submit your application for drug approval to the competent authorities.

**Preparation & communication** — Agency interactions play a central role in the drug approval process. Depending on the procedure, our team of experienced consultants help you interact with all relevant health authorities: Centralized procedure (interaction with EMA, (co)-rapporteur, concerned member state) and National, MRP and/or DCP (interaction with national agencies).

Why QbD Group

## Your trusted partner

Choosing QbD means partnering with a trusted leader in Regulatory Affairs.

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.

Contact us

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