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Regulatory Services

Accelerate the path to regulatory success

To secure successful market authorisation for your animal health or nutritional product, you must navigate a dynamic and complex regulatory landscape. As the world’s only combined global animal health CRO/CDMO, and with a dedicated regulatory affairs team, Argenta is well-equipped to guide you to success.

Navigating rocky regulatory terrain

Plotting a path through animal healthcare regulations can be fraught with challenges.

To succeed, companies must overcome:

Intricate complexity
Companies with their sights set on market release must contend with many regulatory and guidance documents. Finding the applicable regulations can be a resource-intensive task, even for the most well-equipped organisations.
Changing requirements
Animal health and nutrition regulations constantly change. To ensure compliance and avoid costly delays, companies must be able to foresee and understand the impact of regulatory updates, which demands deep knowledge and extensive time. 
Geographical differences
Regulations vary in nuanced ways from region to region. Failing to take account of these hard-to-spot regulatory discrepancies can easily derail a project, drastically increasing programme costs and delaying all important market entry.

Argenta: Deep and collaborative expert regulatory guidance

At Argenta, we’re dedicated to advancing world-class nutrition, treatments, and therapies for healthier and happier animals. To help drive your therapy’s success, we provide collaborative and tailored regulatory services, backed by our extensive knowledge of the animal health, nutrition, and feed additives regulatory landscape.

Registration strategy
and dossier support
We help you craft a well-defined compliant regulatory strategy and right-first-time product dossiers for new products or lifecycle projects, providing everything needed for success. What’s more, we help you prepare for pre-submission meetings with regulators and create quality responses to follow-up questions.
e-Submission
management
We’ll efficiently handle the electronic submission process for all documents (including Technical Sections), promptly answering any questions to ensure the process is as swift and pain-free as possible.
Expert process
guidance
Whatever the challenge or context, our dedicated global regulatory affairs teams are here to guide you throughout the entire process, advising on best practices and how to avoid common pitfalls and maximise chances of success.

Our track record of success

At Argenta, we have a long track record of success, so you can rest assured you’re in good hands:
500+
food and feed regulatory submissions completed
95%
application success rate

Ease the route to regulatory success. Let’s make it happen, together

Want to find out how we can support you on your way to regulatory approval?

Reach out to our knowledgeable regulatory experts today.

A solution for every step of the way

Argenta offers a full range of 'molecule to market' services to help advance your world-class animal health products. Wherever you are in your product development journey, Argenta can help.

Discover our full range of ‘molecule to market’ services: