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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
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