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Regulatory Services

Regulatory Success Starts Here

A strong regulatory strategy and robust technical knowledge is the backbone of the drug development process. You can rely on Argenta for expert guidance throughout the Molecule to Market process, from beginning to a successful end. Our team is well-versed in FDA, EMA as well as EFSA regulatory regulations and processes.

Managing the Complexity of Compliance

No one ever said it was easy. That's why we're here to help. The Argenta Regulatory and Technical Consultation teams in the US and Europe, have a deep grasp of the complexities involved in meeting regulatory requirements on a global level. We bring extensive experience in working with the US Food and Drug Administration (FDA)'s Center for Veterinary Medicine (CVM), the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), and other global regulatory organisations which is crucial to the successful development and timely approval of new veterinary drugs, animal feed, and feed additives.

Our Team Is Your Team

At Argenta, we carry an ethos of partnership with our customers across the product development journey. That means we go where you need us the most, whether it's providing extra regulatory support to your team or taking your regulatory affairs function entirely off your hands.

Reducing Time to Market

We can help maximise the product development process and reduce the time to market with a broad range of regulatory services for veterinary medicinal and animal nutritional products.
Drug Development
  • Help direct the process
  • Manage risk and avoid pitfalls
  • Maintain timelines and budget throughout all development stages
Registration Strategy
  • Craft a well-defined strategy that is compliant with regulations
  • Serve as a US agent for foreign Sponsors
  • Support preparation for pre-submission meetings with regulatory agencies
  • Clarify post-review feedback and help prepare high-quality responses to regulatory agency questions
Clinical and Safety
  • Assist in study design and protocol development leading to concurrence with FDA/CVM and/or EMA.
  • Manage your clinical development program
Chemistry, Manufacturing and Controls (CMC)
  • Design, planning and completion of CMC and cGMP strategies
Electronic Submission
  • Build well-designed Technical Sections complete with Executive Summary and justifications
  • Use FDA/CVM e-Submitter templates
  • Process submissions through the FDA Electronic Submissions Gateway
Post-Marketing Regulatory
  • Help you keep your approved dossiers current
  • Assist in preparation and submission of annual reports and manufacturing change supplements to meet regulatory requirements

Experience Matters

We offer a broad range of regulatory, clinical, and animal safety experience. Our team have more than a century of combined drug development and regulatory affairs experience between them. They have successfully led 50+ product registrations through the FDA/CVM, EMA, and EFSA approval processes.

Related Solutions

Opportunity Assessment
Proof of Concept
Early Development
Full Development
Submission
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Let's Make Healthier Animals Happen, Together

Whether you want to advance an idea, a molecule, or a formulation, Argenta is with you every step of the way.
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Healthy Animals. Let's Make It Happen, Together.

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