Full-scale Registration Batches

General Services

Feasibility assessments
Strategic regulatory advice
Gap analyses
Literature reviews
Dossier preparation and submission
Communication with regulatory authorities
Tailored training sessions

Veterinary Medicinal Products

Immunologicals/Vaccines
Biological Non-Immunological
Pharmaceuticals/Non-Biologicals
Novel Therapies

Animal + Human Nutrition

Feed additives
Feeds
Premixtures
Feed for particular nutritional uses (PARNUTs)
Alternative Proteins
Novel Foods
Alternative Proteins
Enzymes, Additives & Flavours
Foods for Special Medical Purposes
Nutrition and Health Claims

Explore Our Full Range of Solutions

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

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?
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Reach out to our knowledgeable animal health and food & feed regulatory affairs 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.
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Discover our full range of ‘molecule to market’ services:

Full-scale Registration Batches