Consultancy is an integral part of a development programme consisting of many
different elements. We have an unparalleled breadth and depth of expertise and
experience that can be utilised in this capacity. We have internationally recognised
experts representing all the key disciplines including metabolism, environmental
fate, ecotoxicology, mammalian toxicology and regulatory affairs who have had
many years experience both in major multinational companies and at HLS.
This combined experience covers a broad range of different classes of active
substance, and has proved to be invaluable when formulating and scheduling appropriate
development programmes. In addition, we have a network of external consultants
that can be called upon if specialist expertise is required.
The role of our consultants includes, but is not restricted to, the following
:
- Strategic issues on programme design for worldwide registration
- Advice on design of specific studies taking into account existing knowledge
of the compound class
- Providing advice on study-related scientific problems or implications of
new regulatory guidance
- Interpretation of unexpected / unusual results, and advice on further investigations
- Working with our Regulatory Affairs team in the risk assessment process
- Contributing to review of study reports
- Production of independent expert position papers for submission to regulatory
authorities
- Supporting clients in discussions with regulators
|
