Regulatory Services
As part of the essential support for drug and medical device development and commercialisation – Peritus provides regulatory support.
An early consideration of regulatory strategy for product development is essential – this is often overlooked as Regulatory agencies have minimal oversight of drug discovery studies but they do provide their requirements for this stage. However, it is important not to treat this as a ‘tick box’ stage as the data generated will be required to support regulatory filings, and to determine if the drug is safe for first in human trials.
Regulatory aspects are an essential part of the commercialisation and in-market product management. The main Peritus Regulatory services are outlined below – please contact us to explore how we can help you with drug development or medical device regulations & management.