---
title: "Drug Development — Regulatory Affairs | QbD Group"
description: "Drug development entails drug discovery, pre-clinical and clinical testing. New chemical entities need to show minimum standards of safety, toxicity, pharm"
url: https://qbdgroup.com/en/services/regulatory-affairs/drug-development
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Drug Development — Regulatory Affairs | QbD Group\", https://qbdgroup.com/en/services/regulatory-affairs/drug-development"
---

# Drug Development

From discovery to market

Drug development entails drug discovery, pre-clinical and clinical testing. New chemical entities need to show minimum standards of safety, toxicity, pharmacokinetics and metabolism before they can be placed on the market.

## What is drug development?

**From discovery to market: Drug Discovery ⟶ Pre-Clinical ⟶ Clinical Testing**

Drug development entails drug discovery, pre-clinical and clinical testing. New chemical entities (NCE) need to show minimum standards of safety, toxicity, pharmacokinetics and metabolism in animals (pre-clinical testing) and humans (clinical testing) and be **manufactured to high quality standards** before they can be placed on the market.

The drug development process is a very lengthy (up to 10 years) and costly business. Only few NCEs pass all the lengthy testing and make it to the market.

To ensure marketability, drug development programs must **satisfy the regulatory requirements** of drug licensing authorities. The best way to ensure this is to formulate a sound regulatory strategy early on in the drug development process.

## How we support you

Bringing a pharmaceutical product to market requires expertise to ensure compliance, streamline processes, and achieve successful outcomes. Here's how we help:

### Achieve regulatory compliance

We guide you in meeting all regulatory requirements, ensuring your product aligns with the standards of licensing authorities.

### Optimize pre-clinical & clinical testing

We ensure your testing is thorough and appropriate, tailored to the specific needs of your product.

### Customize testing strategies

We help differentiate and address testing requirements for various product types, including NCEs, line extensions, generics, new indications, and bibliographic applications.

Why QbD Group

## Your trusted partner

Choosing QbD means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle.

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 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/drug-development — © QbD Group. Quote freely with attribution and a link back.