A multinational pharmaceuticals group planned to launch a new drug in the European market.
The drug was developed to prevent obesity within the population. Early research showed that besides the benefits offered, potentially it could have negative side effects. The drug had to be seen to be medically safe by regulatory authorities before being granted a licence.
A First Principles consultant worked with the management team on identifying and managing issues while preparing a marketing strategy.
The senior management team were guided through an issues/crisis management plan. Risk assessment was made on the current research results. Issues threatening the drug’s approval, including any negative side effects, were carefully studied.
Where appropriate, we recommended that further product research be done to protect public health and the company’s reputation.
Once the research was completed, we gave advice on how to present the new drug to an influential authority who would decide whether the drug could be marketed across Europe.
The drug was able to meet compliance standards and was granted a licence to be marketed by the European Commission.