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development
mapping out a product
development programme calls for
expertise - find the right partners
and you'll be streets ahead
Sequani offers the
benefit of three decades of experience in pre clinical work, high
level expertise supplemented latterly clinical activities. We are able to undertake
all pre clinical studies needed for the regulatory submission of a
pharmaceutical, from initial 'acute studies' through to
'carcinogenicity'. Using both, dogs and mini-pigs, we undertake
toxicity work in both rodents and non-rodents. All the work we do is
conducted in accordance with Good Laboratory Practice (GLP) and is
suitable for submission to the regulatory authorities.
As is expected of a modern CRO, we also have
the additional support services required to provide clients with a
complete study. This includes formulation chemistry and
bio-analysis, further supported by a toxicokinetic reporting
function.
A specialist area, in which we offer
advanced expertise, is reproductive toxicology. As well as having
completed numerous 'standard' embryo foetal, fertility and pre/post
natal studies, we have also undertaken cross-fostering work and
juvenile toxicity studies. The latter are now in considerable demand
as pharmaceutical companies adapt existing compounds for paediatric
use or elect to investigate paediatric indications at an earlier
stage in a product's development. Regulators too are intensifying
their focus on this area.
As always it's a matter of acquiring the
vital data that helps you to map out the way forward. Sequani can
help.
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