Regulatory Affairs Services for Veterinary Products

Services We Offer

Artixio’s expertise has led to over 35 successful veterinary product approvals. Our streamlined regulatory services and in-depth knowledge empower our clients to achieve efficient and accelerated market entry.

Regulatory Affairs Services for Veterinary Products

Artixio holds a comprehensive knowledge base of global and regional veterinary product regulations, covering a range of products including veterinary medicine, animal feed additives, diagnostics, devices, etc. We leverage methodical and efficient processes for dossier preparation, submission, and communication with regulatory agencies worldwide

It is essential to obtain approval for veterinary products to ensure responsible and ethical use of veterinary products, failing which the consequences can be severe, impacting animal health, public safety, and the company’s reputation and financial stability.

Veterinary Product Registration Pathway

Pre-registration

Veterinary Regulatory Compliance and Strategy
Prioritization of Animal Health Products
Veterinary Market Research
Animal Health Product Dossier Review and Gap Analysis
Due Diligence of Veterinary Product
Veterinary Product Market Access Strategy

Registration

Animal Health Product Registration and Liaison
Veterinary Product Dossier Preparation
Animal Health Product Label and Packaging Review
Veterinary Health Authority Meetings and Liaison
Veterinary Health Authority Audit Support
Veterinary eCTD/CTD Publishing and Submission

Post-Registration

Veterinary Product Lifecycle Management
Veterinary Product Label, Packaging, and Advertising Material Review
Veterinary Product Line Extensions and Variations
Response to HA Regulatory / Safety Queries
Response to Veterinary Health Authority Regulatory and Safety Queries
Veterinary Product Distribution and Import Support

Artixio’s Core Competencies

Why Artixio

FAQs

How can a robust regulatory strategy contribute to our company's overall business objectives for our veterinary product?

We believe that it directly contributes to your business objectives by reducing development costs, strengthening investor confidence, and providing a competitive edge.

What metrics does Artixio use to measure the success of a veterinary regulatory strategy?

We employ key metrics such as time to approval, approval success rate, budget, and compliance adherence.

What are some of the biggest challenges companies face in global veterinary regulatory affairs?

Evolving regulatory landscapes and varying requirements are some challenges and Artixio helps you overcome them through expert guidance and tailored strategies.