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Regulatory Affairs



In-depth knowledge of the regulatory background for



  • Pharmaceuticals
  • Immunologicals
  • Biologicals
  • Feed Additives
  • Feed

Smart regulatory strategies for



  • MUMS (Minor use-minor species) products
  • Generics
  • Innovative products
  • Borderline products

Strategic consultancy



  • Development of a tailor-made strategy for your unique product
  • Gap analysis- data audit
  • Literature research
  • Consultancy with regulatory authorities
    • Pre-submission meetings
    • Scientific Advice

Preparation and submission of regulatory documentation



  • Compliance check of labels and product material
  • Expert Reports
  • MUMS applications
  • MRL dossiers
  • Marketing authorisation dossiers – complete or in parts, full or abbreviated
  • Electronic and/ or paper based submissions
,
  • Consultancy with regulatory authorities
  • Dealing with questions


 



Contact Person


Dr. med. vet. Beate Lohr Send an E-Mail

Dr. med. vet. Beate Lohr

Head of Regulatory Affairs


Support during your registration process




Life cycle management



  • Handling of
    • Modifications
    • Variations
    • Renewals
  • Post-authorisation monitoring
  • Pharmacovigilance