Regulatory Affairs

Quality assurance and regulatory affairs can hardly be separated. That is why Quality by Design offers you the complete package. 

We not only take care of quality management, but also support you during the entire life cycle of your products, whether they are traditional pharmaceutical products, generic medicines, vaccines, biologicals, biosimilars, medical devices, or Advanced Therapy Medicinal Products (ATMP).

Our consultants offer extensive regulatory affairs knowledge and expertise to support your team or insource complete regulatory affairs projects – all in an efficient and pragmatic manner.

Our RA services


Regulatory Affairs for Pharma and Biotech

QbD’s consultants offer comprehensive knowledge and expertise when it comes to regulatory affairs for pharma and biotech.

Regulatory Affairs for Medical Devices

Need regulatory affairs support for your medical device? We offer the guidance you need to navigate through complex regulatory requirements.

Regulatory affairs for IVDs

Loking for quality, regulatory or clinical support for your IVD medical device? We can support you at any stage in the lifecycle of your IVD.

Performance Evaluation Studies

Do you need compliant clinical evidence for your IVD device? We are happy to support you with your IVD Performance Evaluation Studies.

In-country Representative Services

Do you require representative services for your medical devices and/or IVDs? QbD’s Qarad is an independent partner that can act as EC-REP, CH-REP, or UKRP.

Legal Representative Clinical Trials

Are you a sponsor with offices outside the EEA and wish to conduct a clinical trial within the EEA? QbD Clinical can act as your legal representative.

Person Responsible for Regulatory Compliance (PRRC)

Are you looking for a Person Responsible for Regulatory Compliance (PRRC) for your medical devices and/or IVDs?

Pharmacovigilance & Drug Safety

The QbD Group provides strategic and operational support for partial or full outsourcing of Pharmacovigilance (PV) responsibilities.

Technical Documentation & Clinical Evidence

Our device compliance team has the expertise to address any question or need related to clinical evidence and technical documentation of your IVD.

Why QBD Group?


QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient.

With more than 450 experts in various fields including RA, QbD is your partner for regulatory advice and support.

Experience icon

10+ years of experience

Full cycle support icon

Full life cycle support

Global presence icon (2)

Global presence

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Best Managed Company

Contact us


Need help with your Regulatory Affairs? Don’t hesitate to get in touch.

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.