Regulatory affairs & regulatory advice
Specialist assistance on regulatory affairs for the pharmaceuticals market
Here at H&T Presspart we have a dedicated team who are able to assist our customers in pharmaceutical regulatory affairs to ensure that both we and our customers are up-to-date with current legislations in the pharmaceuticals industry, with regards to the safety and efficiency of our products.
We have over 25 years’ experience of compiling ‘packaging material’ Drug Master Files (DMFs) to support customer submissions with the FDA (Food and Drug Administration) and Health Canada, and we currently have 11 active DMFs in place for various metered-dose cannister specifications, metered-dose inhaler actuators and other drug delivery/packaging components.
We have established strong partnerships with contract laboratories for Extractables and Leachables testing, as well as other specialist analytical services. We can also assist with product registrations for plain (uncoated) MDI cannisters in place with Chinese SFDA (State Food and Drug Administration.)
Get in touch with us today to find out more about how we can assist with regulatory affairs.