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Regulatory Affairs

Navigating regulatory complexity for animal health and nutritional products

Challenges with regulatory submissions often delay animal health and nutrition product launches, affecting your return on investment (ROI) significantly. Our team is experienced in the regulatory requirements and processes for all major markets and can provide bespoke guidance, submission writing, or even take your regulatory affairs function entirely off your hands.

Successful animal product registration requires deep technical understanding

A strong regulatory strategy and robust technical knowledge are fundamental for successful registration of animal therapeutics. Without the right guidance and support, cutting through regulatory complexity can be challenging.

Regulation is nuanced
and complex
US, European, and other global regulators have stringent requirements for the safety, efficacy, and quality of animal therapeutics, which can differ by market. A lack of nuanced knowledge around global regulatory processes and technical requirements can put successful registration at risk.
Evidence must
be compelling
Successful registration requires robust clinical evidence and a strong value proposition, built within a well-designed submission document that includes technical insights and justifications. When regulatory feedback arrives, you’ll need to deliver timely, high-quality responses to avoid delays.
Delays can derail your
product launch
A lack of strategic planning for regulatory submission can lead to unanticipated safety concerns, and incomplete or inconclusive clinical data. Such issues can lead to challenges in meeting regulatory requirements and the potential need to repeat trials, prolonging the path to market approval.
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An experienced partner for regulatory strategy and submission

Deep technical
expertise
With extensive experience working with the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), and the US Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM), and other organisations, we enable timely approval of new veterinary drugs, animal feed, and feed additives.
Experts in regulatory
strategy
Our global team of regulatory experts has a proven track record of  submissions. We’ll craft a robust regulatory strategy, support pre-submission meetings with regulatory agencies, help clarify agency feedback, and prepare high-quality responses to agency questions.
Compelling, robust
submissions
Our deep network, experience, and technical knowledge combine to enable efficient negotiation and rapid responses to regulatory agencies. Our experts develop comprehensive submissions, featuring an Executive Summary and robust justifications, to ensure a smooth submission.
Helpful, transparent
communication
Our open, transparent approach to client partnerships helps streamline workflows and ensure on-time delivery. As part of this, our team will guide you carefully through the registration process, ensuring alignment and quality control at every stage.
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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: 
50+
product registrations through the FDA/CVM, EMA, and EFSA
EMA, FDA & EFSA
expertise and strong networks with regulatory agencies around the world
Reduced costs & saved time
for clients via Regulatory & Development Roadmaps 

Related solutions

From ‘molecule to market’, Argenta offers a comprehensive package of services to support your commercialisation goals. Wherever you are in your product development journey, we can help.

Early Development
Evaluating product efficacy and safety to help de-risk development
Clinical Development
Effectively designing studies to maximise success in pivotal clinical trials
Regulatory Services
Navigating regulatory complexities to achieve successful registration
Partner with us

Healthy Animals.
Let’s Make It Happen, Together.

From 'molecule to market', Argenta has the expertise and capabilities you need to realise your animal health product.
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Healthy Animals. Let's Make It Happen, Together.

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