Approach To The Drug Approval Process...

 A regulatory affairs professional needs to provide an interpretation of the data and the regulations in order to:

  • foresee hurdles and develop options to mitigate/address them in advance or resolve them

  • facilitate/convey the development plan to an agency at each critical milestone

 The regulatory professional is a strategic partner ensuring the creation of sound plans to meet global regulations and integral to the scientific dialog within a company and with external stakeholders.