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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
