Regulatory Affairs

In-depth knowledge of the regulatory background for

  • Pharmaceuticals
  • Biologicals incl. Immunologicals
  • Feed Additives
  • Feed
  • Other (e.g. diagnostics, hygiene products)

Smart regulatory strategies for

  • MUMS (Minor use-minor species) products
  • Generics
  • Innovative products incl. platform technologies
  • Novel therapies
  • Borderline products

Strategic consultancy

  • Development of a tailor-made strategy for your unique product
  • Gap analysis - data audit
  • Literature research
  • SME and MUMS applications
  • Consultancy with regulatory authorities in EU and 3rd countries
    • Pre-submission meetings
    • Innovation task force (ITF)
    • Scientific Advice (SA)
    • Consultation with national competent authorities

Preparation and submission of regulatory documentation for application of marketing authorisations

  • Compliance check of labels and product material
  • Expert Reports (DACS)
  • Preparation and support for agency meetings (e.g. ITF, SA)
  • MRL dossiers
  • Marketing authorisation dossiers – complete or in part, full or abbreviated
  • Electronic and/ or paper based submissions
  • Consultancy with regulatory authorities
  • Support with response to questions for dossier


Contact Person

Dr. med. vet. Cornelia Hüttinger Contact

Dr. med. vet. Cornelia Hüttinger

Head of Regulatory Affairs

Life cycle management and consultancy

  • Full support for logistics and launch activities
  • Handling of
    • Modifications
    • Variations
    • Renewals
  • Post-authorisation monitoring

Veterinary Pharmacovigilance (PhV)

  • PhV Master Files
  • Detailed Description of the PhV system
  • Act as Qualified Person for PhV
  • Case reporting
  • Periodic Safety Update Reports
  • Product Quality Review