›› KLIFOVET › TARGET INDUSTRY › VETERINARY MEDICINAL PRODUCTS


Veterinary Medicinal Products (VMPs)



Broad experience in the development of



  • Pharmacological products:
    • Antimicrobials
    • Anti-inflammatories
    • Antiparasitics
    • Hormones and Reproduction
    • Sedatives and Narcotics
    • Products used in internal medicine (e.g. cardiology, oncology, nephrology)
    • Products with metabolic effects
    • Others
  • Biological and immunological products
    • Vaccines
    • Allergen Products
    • Biopharmaceuticals
    • Others

Product development



Full project management from the idea to market
 

  • Thorough SWOT analysis of your product, identifying marketing potential and suitable claims
  • Assistance in SME or MUMS applications
  • Assistance in contract manufacturing search and tech-transfer process
  • Development plan, estimating time and cost to market
  • Assistance in Due Diligence Process*
  • Assistance in search for development, distribution and marketing partners*
  • Selecting partners, placing and supervision of studies assuring required standards (e.g. OECD/FDA/EPA GLP. VICH GCP)


* with partners

Strategic regulatory consultancy



  • Gap analysis- and/or Data Audits
  • Literature research
  • Consultancy with regulatory authorities
  • Scientific advice


 



Evaluation and compilation of dossiers



  • Evaluate current dossiers and update them to current standards
  • Write and compile dossiers
  • Manage national and international applications for Marketing Authorization
  • Manage variations and line extensions of Marketing Authorizations
  • Renewal of Marketing Authorization
  • Transfer and update paper based dossiers into new electronic format
  • Compliance check of labels and product material
  • Translations
,
  • Assessment of potential antimicrobial activity
  • Strategic consultancy how to bring products to market
  • Expert Reports on antimicrobial resistance

Microbial studies




Studies



  • Consultancy on protocol and reports
  • Full management of GxP studies in animals
  • Study Design
  • Placing of studies based on our long-standing reliable network of sites in Europe

Quality assurance and management



  • Establishment Quality Management Systems (QMS) in facilities
  • Process definition and implementation
  • Development of Standard Operating Procedures (SOPs)
  • Training
  • Audits
    • Facilities
    • Processes
    • Studies

Annual conferences on selected topics and new developments in feed and feed additives