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

Dr Hannah Lester | Amgen Consulting

Dr Hannah Lester
CEO & Principal Consultant

Hannah is a regulatory affairs expert with over 15 years experience in developing veterinary, animal feed and food products for regulatory approval in the EU and other global markets.

She has worked on cell-cultured products, plant protein isolates, fermentation products, algae and seaweeds, and traditional foods - preparing regulatory plans, providing support on study design and statistics through to preparing novel food dossiers & traditional food notifications.

She is passionate about alternative proteins and helping companies navigate the complex regulatory requirements needed for regulatory approval.

Hannah is regularly invited to speak about alternative proteins and regulations at international events. She is an expert for the Protein Directory and a Principal Consultant for Bright Green Partners. She's  a mentor for Big Idea Ventures and the ProVeg Incubator, and is a scientific and regulatory advisor for KindEarth.Tech

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Rosalia Flores Vidal
Regulatory & Novel Food Specialist

Rosalía is a biotechnologist with over 5 years’ experience in food and feed regulations.

She has extensive experience with novel food registrations and has worked on plant based, fermentation, precision fermentation and cell cultured meat projects.

 

She has worked on some pioneering alternative protein dossiers in the EU and other markets and brings with her a huge amount of knowledge and experience.