Compliance Specialist

Are you looking for support in the implementation of the latest pharmaceutical and/or medical device regulationsAt QbD, we can offer you a complete solution with the help of our compliance specialist team. 

We can support you in the entire product lifecycle, from research to post-authorization activities. Find out more about our compliance specialist services below.

Compliance Specialist - Quality by Design

What is a Compliance Specialist?


As a life science organization (pharmaceuticals and/or medical devices), you need to be compliant with the latest applicable standards to keep your marketing authorization status. This is important to guarantee the safety and efficacy of your products. 

Noncompliance can lead to major sanctions by regulatory health authorities (i.e. warning letter, withdrawal of marketing authorization), reputational damage or financial losses.

Due to the heterogeneous regulatory network, different countries and regions will have specific standards. Due to this variety and the changing industry environment, companies can face certain challenges (e.g. resources, competences) to implement these new standards in their current processes.  

QbD’s compliance specialists can offer you support and guidance to maintain the quality compliance level of your company and to assure the quality, safety, and efficacy of your products.

Why QbD Group?


QbD can ensure that your company is aligned with current and upcoming Health Authority standards. This will allow you to react to market demands in a timely manner and in compliance with current regulatory obligations.

Furthermore, we can help you to increase your “first pass” audit success rate by supporting your continuous improvement projects and by preparing your site for health authority inspections.

We offer compliance support from the research/development phase to marketing authorization application and post-authorization activities. We have experts in:

Our compliance specialists can provide day to day compliance management. Here you can find a non-limited overview list of our support capabilities: 

Compliance Specialist - Quality by Design (1)


Frequently Asked Questions about compliant specialists
  • Failure to follow procedures and/or records
  • Failure to detect correct root cause (deviation and CAPA investigations)
  • Failure in laboratory controls

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) aims to harmonize guidelines to ensure that high quality medicines are developed worldwide 

Contact us


Contact us for more information or request a free, no-obligation proposal.

Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.