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Product Development



From the Idea to Marketing Authorization for Animal Health and Nutrition products



Small and Medium Enterprises applications



Support in submitting and handling of SME applications to authorities (Europe, USA and other countries).
For further information see also the agencies websites.

EMA
FDA

Minor Use Minor Species (MUMS) applications



This type of applications may allow for abbreviated packages that are needed to be submitted.

  • Support in applications for MUMS
  • Literature search
  • Marketing research
  • Preparing the justification and application for MUMS

For further information see also the agencies' websites.

EMA
FDA

SWOT analysis



Analysis of Strength Weaknesses Opportunities Threats for a product with emphasis on

  • Regulatory path
    • as a VMP global approach, centralized , decentralised, mutual recognition or national procedures)
    • as a feed additive
    • as feed
    • as other product (in case of borderline product)
  • Classification of a product
  • Market research and / or respective questionnaires
  • Define where further partner support (e.g. CMO, distributor(s), PhV) is required
  • Define advantages / disadvantages of different scenarios

GAP analysis



Evaluation of GAPs that need to be filled based on a regulatory GAP analysis and / or SWOT


Product Development Plan



  • Based on GAP Analysis and/or SWOT
  • Studies to be conducted
  • Cost estimation of development programme
  • Time horizon of development programme




 



Contact Person


Dr. med. vet. Regina Wolf Send an E-Mail

Dr. med. vet. Regina Wolf

Head of Product Development, MBA


Selection of Partners



  • Define activities to gain finances
  • Define activities and requirements for CMO selection
  • Assist in selection of distribution partners

Full development project management



Coordination of implementation of development plan/programme

  • Obtain offers from different suppliers/partners
  • Assist in selection of suppliers for studies (advantages/disadvantages)
  • Study outlines
  • Evaluate suppliers for studies
  • Place studies
  • Overview/monitoring of studies
  • Review of protocols reports
  • Co-ordinate timelines for studies within the project to assure that submission timelines can be met
  • Coordinate activities with other partners (e.g. CMO, Regulatory Authorities, Sponsor)
  • Provide regular updates on status
  • Problem solving support

Products



  • Pharmaceuticals
  • Immunologicals
  • Biologicals
  • Feed Additives
  • Feed