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Regulatory/Registration
Novus -Bridge regulatory consulting and intelligence team is comprised of regulatory experts with extensive experience in product development, preparation of registration strategies and successful registration of products with regulatory authorities regionally.
We cover the following broad areas in regulation and registration in the agrochemical industry in Kenya
- Strategy
- Post Approval
- Regulatory Intelligence Services
Strategy
Post approval
Regulatory intelligence surveillance
Strategy
Successful application for marketing authorization of agrochemicals require a strong scientific approach and positioning the product appropriately .Guidelines and regulations will keep changing globally and regionally and therefore a robust regulatory strategy is key .In absence of coherent regulatory /registration and development strategy then the product will be prone to failure or unsatisfactory performance at the initial stages of development .Devising a good regulatory strategy is not just a matter of grasping the regulations and guidelines but requires proven experience, understanding of science behind the product , market and a network of key agencies contact which are invaluable tools for obtaining rapid responses to informal questions . Novus-Bridge have a track record of success with applications for authorizations .
What we offer :
- Overall regulatory strategy for agrochemical registration and development
- Compilation of dossier structure – Showing the require documentation
- Organizing meetings with regulators ,
- Amending strategy following review meeting with authorities .
Post approval
Our services do not end after successful marketing authorization , we continue to monitor the product and market evolution and suggest a variation from the market perspective or the principle may change its sourcing strategy and therefore become imperative that the variations are necessary Novus-Bridge will help in developing strategies , compilation of submissions and timing for post registrations variations which will include :
- Addition/change of source for active ingredient /formulation sites
- Formulations change
- Label extensions
- Continuous monitoring
- Parallel registration justified by clear market / Channel segmentation
Regulatory intelligence surveillance
Regulatory intelligence is a vital component for successful product development. In order to ensure that current regulatory requirements and future regulatory trends are implemented, access to a source of the most recent developments is essential
In East Africa such information does not exist and this coupled by constantly changing regulations and emerging issues in regulatory environment makes it difficult to follow. Novus-Bridge will follow and provide this information service that allows you to stay up-to-date with the dynamic and challenging individual country regulatory environment in East Africa. Such information allows you to understand the significance of key regulatory documents and their potential impact on your current and future product portfolio.