They realise that generalisations such as ‘The FDA says’ or ‘The EMA says’ may not be solid and will help avoid the situation of untested generalisations. We have frequent dialogues with the regulators and can help you with the practical implications of regulations.
Axcellant regulatory team have built a strong reputation with global regulators and even our competitors use our regulatory services.
Our skilled team of professionals brings together a wealth of experience garnered over numerous successful projects
We provide clarity where there is ambiguity and find opportunities when there is uncertainty.
Our operations team have broad and deep insights in the local ethics and regulatory framework.
We appreciate data is our common currency for a range of eventualities.
Our regulatory team masterfully apply critical thinking when defining the regulatory strategy.
Our systems, processes and training have been developed with a quality by design approach.