Services

Regulatory Affairs

Veterinary Medicines

Starting 28th of January 2022, the Veterinary Medicines Regulation (Regulation (EU) 2019/6) introduces a modern framework for the authorization and use of veterinary medicines across the European Union.

Whether launching new products or updating existing ones, we provide cost-effective regulatory planning to navigate these changes efficiently.

How to Reach us?

Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202

1000 Ljubljana

Slovenia

Our services include:

  • Guidance through every step, ensuring compliance with the Regulations
  • Updating and reformatting your product documentation to meet new standards
  • Selecting the appropriate procedure to managing VNeeS submissions and EU-wide registrations
  • Preparation of all necessary documentation, including CMC for APIs and FDFs,
    and managing MRL applications
  • Offering services from lifecycle management to conducting Environmental Risk Assessments (ERA) to align with EU sustainability goals

More ways,
we can help.

With a focus on expert guidance and strategic insights, we propel your projects forward with confidence, ensuring every step is handled with precision.

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