GEM can provide strategic guidance for submission preparation to key agencies including FDA, EMA, PMDA. We can also support responses to regulatory agencies, both written questions and formal meetings such as advisory committee meetings.
Our senior consultants have hands-on expertise in successfully delivering many submissions and marketing applications with all the key Regulatory Agencies, including FDA, PMDA and EMEA. We have successfully led programming teams in submission work and response teams at FDA Advisory Committee meetings.
We have had the opportunity to attend these meetings in person, working in the ‘war room’ adjacent to the public FDA meeting delivering real-time data displays to support the recommendation for approval for a drug asset.
With our background we are confident we can support your organisation to facilitate a successful submission; in all sorts of ways GEM helps you get stuff done!
GEM as an organisation has its own internal training development program and we are looking to make some of that available to our clients on request. Also, as we make novel developments in how we deliver projects internally, we will post some of those methodologies on this website. If you see anything that you would like to use just let us know.
We are happy to do 1:1 training or generate a full-blown training package. Alternatively, if you just want someone to bounce ideas off why not drop us an email and we’ll see what we can do.