RWR-Regs Solutions…

As the regulatory landscape continues to evolve, it’s crucial to stay informed about the latest updates. Fortunately for you, RWR-Regs provides comprehensive, up to the minute information on real world research (RWR). From changes in non-interventional study regulations to updates on data privacy laws, RWR-Regs keeps you in the know. But that’s not all. We provide consulting on study design and operational delivery, a wide range of training courses and country specific regulatory roadmaps. With RWR-Regs, you’ll always be up-to-date.

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Simple tools…powerful results

NIS Regulatory Requirements

Everything you need to run a non-interventional study…in one place.

Don’t just take our word for it…click on the button below to access the NIS regulatory requirements for Germany.

NIS Training

Learn about the country-specific requirements for non-interventional studies…and keep up to date with our annual refresher training.

RWR Regulatory Updates

Keep up to date with changes to global real world research regulations and guidelines with our monthly regulatory intelligence reports…packed with impact assessments, real world research context and insights.

Created for real world research experts by real world research experts.

EU MDR Roadmaps

Country-specific roadmaps of the EU Medical Devices Regulation (Regulation EU/2017/745) regulatory requirements for pre- and post-approval medical device clinical investigations in the EU.

Click on the button below to access the EU MDR Roadmap for Germany.

RWR Regulatory Update - July 2022
RWR Regulatory Update - June 2022
RWR Regulatory Update - May 2022

Regulatory Updates – User Feedback

“I love the context summary. This is the element that we struggle with, whilst we are often able to identify and collate the intelligence, it takes more resource to agree what the impact might be or to decipher what the crux of the change is.” [Executive | Top 5 Pharma]

“I personally like the RWR context piece as it tells me whether this article is something I need to read now or whether it can be read later.”

CEO | Regulatory Consulting

“Aggregation of relevant content from multifarious sources into a digestible and readily available publication. Immediately user-friendly. Easily navigated.”

Founder and CEO | Records Management, Information Governance and Digital Preservation

“An indispensable tool in the armour of Real-World Evidence practitioner and professionals. (“Don’t leave home without it” 😊😊)”

Founder and CEO | Records Management, Information Governance and Digital Preservation

“Alternatives to this product?… the pain and suffering of vast web searches—no known competitor.”

Managing Director | Digital RWE Consultancy

“Real world regulatory intelligence – a platform in the form of a report that provides access to every level of detail needed”

Managing Director | Digital RWE Consultancy

“The extensive use of internal links and external links is fantastic; this makes the report more of a valuable tool, that is, more like a navigation platform.”

Managing Director | Digital RWE Consultancy

“I really like the margin comments, which provide a brief overview of the content for someone looking at high level details.”

Managing Director | Digital RWE Consultancy

“A great overview of requirements with links to details in case you need them”

Ex-MHRA Inspector | UK

“Alternatives to this product?… Hours with Mr Google and then Google translate! Calls to colleagues who have access to Cortellis (that seems to be about the only system everyone uses)”

Ex-Regulatory Inspector

“A godsend if you have been asked to monitor the external environment!”

QA Executive | Top 10 Pharma

“A report that expertly synthesises external instructions for the execution of real world research.”

QA Executive | Top 10 Pharma

“…provides a heads up, a “What it means for me” and a deciphered summary of the change, amendment or new regulation.”

QA Executive | Top 10 Pharma

“High quality, easy to navigate content”

QA Executive | Top 10 Pharma

“I really like that you can hone in on the sections that you want to read first and can then navigate around the documents very quickly.”

QA Executive | Top 10 Pharma

“The useful resources sections are a really good inclusion”

Executive | Top 5 Pharma