Amgen Regulatory Consulting provides scientific and regulatory advice to the alternative protein industry. Amgen is the first regulatory consultancy to specialise in alternative proteins and we are passionate about helping companies of all sizes get these vitally important products through regulatory approval in the EU and other global markets.

Amgen was founded in 2022 and means "alternative" or "better" in Welsh. Amgen Regulatory Consulting believes in "alternative" proteins and believes in a "better" future.  

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Working towards
a better future

Our Expertise

We have extensive experience with all types of alternative proteins falling under the novel foods, traditional foods, GMO food & animal feed categories.

We offer regulatory and scientific support wherever you are in your product development journey. We can offer support at the initial stages, helping you to check the regulatory feasibility of your product through to dossier compilation, submission & post-submission stewardship.

Novel food

We specialise in novel food registrations in the EU & other global markets

Traditional food

Traditional foods are foods consumed in a third country with a safe history of use

Plant protein

Proteins or ingredients derived from plants, algae or seaweed

cell cultured

Animal feed or food products derived from cell culture

Fermentation

Food or food ingredients derived from fermentation or precision fermentation

Insect protein

Food and food ingredients derived from insect protein

GMO food

Food containing or produced from genetically modified organisms

Animal feed

Animal feed ingredients should meet the nutritional requirements of animals

We offer support
every step
of the way

Regulatory feasibility

• Is your product going to pass regulatory approval?

Regulatory roadmaps

• What are the data gaps & what do you need to do to get approval?

Which studies?

• Which studies do you need to perform to support product approval?

Dossier 

• We can help with dossier compilation, submission & post-submission stewardship

Approval

• We can offer post-approval support and liaise with regulatory authorities

Global regulatory planning

• We can help you with your global regulatory planning & strategy

Regulatory Reach

Amgen offers regulatory services in the EU, UK, USA and Singapore.

 

Through our network of trusted regulatory partners we are also able to offer regulatory services in other major global markets.

For more information about our services & which markets we can cover:

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"Amgen believes in "alternative" proteins & "believes" in a "better" future"

Meet Amgen

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AMGEN Regulatory Consulting is a small but mighty female-led team of regulatory experts based in Barcelona with a shared passion for helping to build a more sustainable future through revolutionising the way we produce food.

 

We are passionate about the important role of new food and feed technologies, and are proud to help companies on their regulatory journey to gaining market approval.

We live by our name Amgen, which means alternative or better in Welsh. We are passionate about alternative proteins and foodtech, and we believe in a better future. We are also alternative in our thinking and our approach, and we believe that consulting can be done better.

 

We are 100% customer focused and we believe in “no surprises” consulting where our clients can expect excellent work, which is delivered to agreed timelines and budgets.