The programme is designed to evaluate the hazard associated with the active
substance and the potential exposure resulting from its proposed use. The data
are combined to assess the risks.
- Human health effects – toxicology, metabolism and residues
- Environmental impact – environmental fate and ecotoxicology
It is essential to plan studies on all aspects simultaneously to minimise development
time, since the initial studies and risk assessments may result in the need
for higher tier work. It is by working in partnership with our clients that
strategies for the various stages of the programme are agreed and adopted.
Our Programme Directors will work with companies to help make decisions on
key strategic issues for the successful development of their compound / product.
Certain key information needs to be obtained at the beginning or early in the
development programme:
- Intended dates of submission of dossier worldwide
- Intended use (GAP) and potential markets
- Formulation type(s)
- Radiolabelled test substances
- Test material source and supply
We can design single studies to meet worldwide requirements (e.g. EU / US /
Japan), as well as conduct those additional studies that may be necessary to
satisfy the particular requirements of the US and Japan.
Completion of the programme in minimum time then requires:
- Intensive interaction between HLS and the client
- Good management and use of information / knowledge
- Good integration between study types
- Liaison with the appropriate regulatory authorities
- Timely decision making
- Regular risk assessments – triggers for further work
- Willingness to commission higher tier studies promptly
- Ongoing production and development of the regulatory dossier throughout
the work programme
Each of the completed and ongoing compound development programmes has been
different, and it is this unique experience that sets HLS aside from our competitors.
We have a track record that speaks for itself!
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