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 as well as EMA 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), and other global regulatory organisations which is crucial to the successful development and timely approval of new veterinary drugs.

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.

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 half a century of combined drug development and regulatory affairs experience between them. They have successfully led 30+ drug product registrations through the FDA/CVM and EMA approval processes.

Regulatory Services

Regulatory Success Starts Here

Managing the Complexity of Compliance

Our Team Is Your Team

Reducing Time to Market

Drug Development

Registration Strategy

Clinical and Safety

Chemistry, Manufacturing and Controls (CMC)

Electronic Submission

Post-Marketing Regulatory

Experience Matters

Related Solutions

Opportunity Assessment

Proof of Concept

Early Development

Full Development

Submission

Partner with us

Let's Make Healthier Animals Happen, Together