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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