Services

From product development to regulatory submissions and data management. We cover every stage your Animal Health product needs to reach the market and stay there.

01

Product development

Getting your farm animal health or nutrition product approved in the EU or US is just the beginning. The scientific data you've already generated is a strategic asset. One that can open doors in South America, Asia, Africa, and Australia without starting from scratch.

Every market comes with its own regulatory landscape, timelines, and cultural nuances. We build and lead the cross-functional teams that turn that complexity into a clear, executable global development plan aligned with OECD and VICH guidelines from day one.

Assessment & Strategy

We evaluate the regulatory landscape of your target markets and build a tailored roadmap before any development begins.

  • Assess regulatory requirements for each target region
  • Define timeline, budget, and risk mitigation strategy
  • Align the development plan with OECD and VICH guidelines

Data & Product Development

We identify data gaps, design the studies needed to fill them, and optimize your formulation to meet the specific requirements of each target market, including regional species conditions and production contexts.

  • Gap analysis based on existing EU/US regulatory data
  • Study and trial design for livestock species
  • Formulation optimization for regional conditions
  • Adaptation to local ingredient availability and standards

Regulatory Submission

We compile, standardize, and submit your regulatory dossiers. Managing the full dialogue with authorities so you can focus on your product, not on paperwork.

  • Preparation of region-specific regulatory dossiers
  • Internal accuracy and compliance reviews
  • Direct communication with regulatory agencies
  • Response management for authority queries

02

Trainings & Workshops

Stay ahead in animal health and nutrition with practical training designed for professionals who need to apply knowledge, not just acquire it.

  • Animal nutrition training: Basic and advanced levels for livestock species
  • Statistical methods for research and clinical trials
  • Quality standards for study conduct (GCP, GLP)
  • Regulatory pathways for marketing authorizations in feed additives and veterinary products
  • Strategies for borderline product development in farm animal health

03

Regulatory Affairs

Navigating regulations across markets is complex. We bring the expertise to keep your livestock products compliant and ready to compete, wherever you operate.

  • Product safety and quality assurance for feed additives and veterinary products
  • Labeling and claims compliance for farm animal markets
  • Nutrition and formulation standards per species (cattle, swine, broiler, sheep/goat)
  • Regulatory submissions and product registration
  • Import/export compliance for international markets

04

Data Management and Analysis

Good data is the backbone of every successful regulatory submission. We manage the full data lifecycle, from capture to analysis, using electronic and paper-based systems tailored to your livestock study design with your preferred EDC platform, or our custom data management plan built specifically for animal health studies.

Data Management

We handle all data management needs for any type of farm animal study, ensuring accuracy, traceability, and compliance at every step.

  • Study-specific database setup
  • Custom data capture forms
  • Double data entry option
  • Query generation and resolution
  • Full audit trail
  • Data management plan and report
  • Data listing and transfer in any format

Data Analysis

Our preferred system is R universe, developed as an open source reproducible statistical programming language specifically for animal health covering cattle, swine, broiler, and small ruminants with equal precision.

  • Study-specific database programming
  • Individual access with password identification
  • Treatment allocation and blinding
  • Role assignment per team member
  • Online plausibility checks and query management
  • Full audit trail and system validation
  • Setup ready in under 4 weeks from protocol sign-off

Your product deserves the right team behind it.

Let's collaborate together

Real results, from real teams.

These are the people who trusted us with their products. Here's what happened next.

Thomas Reiner

We had solid EU data but no clear path into Southeast Asia. Ame-K mapped the regulatory landscape in weeks and built a submission strategy we could actually execute. First approval came six months ahead of schedule.

Head of Scientific Affairs

Thomas Reiner

Sara Lindqvist

We needed a sharper product story and a partner who understood both claims and commercialization. The team helped us structure the offer, tighten the dossier, and move much faster with distributors.

Head of Business Development

Sara Lindqvist

The latest thinking in animal health and nutrition. From our team to yours.

Publications

Nutrition plans for pets with chronic conditions

A structured approach to dietary support for ageing, recovery, and disease-related cases.

Clinical Nutrition Team · 21.01.2026

Precision feeding for modern livestock operations

Precision feeding for modern livestock operations

How to connect formulation, compliance, and performance targets in a single nutrition workflow.

What to prepare before a first nutrition consultation

The information that helps us move faster from diagnosis to a practical nutrition roadmap.

Ame-K Advisory · 04.12.2025