Services: Regulatory Strategy, Guidance & Support
The Life Science Industry is the most regulated industry. Medicines used to treat chronic diseases to the common cold would not be available to patients without the teams of specialists (including regulatory affairs professionals) who work to ensure that these medicines gain approval from the relevant Health Authorities, such as the MHRA and the US Food & Drug Administration (FDA).
A good regulatory affairs professional will maintain their awareness of changes in regulations which can affect clinical trials and regulatory strategy etc. In addition, new areas of regulation appear because of technological advances and so they have to continually learn and gain experience in these new emerging fields. They are often key to deciding the best regulatory route to take in order to be successful in obtaining a product licence for the company they are representing and to stay ahead of the competition. An ever increasing number of regulatory affairs professionals include highly trained scientists and medical professionals who are able to influence the overall drug development process.
GRS has a global team of regulatory affairs specialists who ensure their skills are kept up-to-date. We can advise on regulatory development projects and overall strategy (including an evaluation of the available regulatory procedures) in order to determine the best possible outcome for our clients both strategically and commercially.
Please contact us with your specific regulatory compliance requirements.