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.

Presspart Regulatory Affairs team

MDI cans

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About Presspart Drawing on 42 years of success, Presspart Manufacturing Ltd has developed in to a World-leader of bespoke deep-drawn and injection moulded components, with manufacturing plants located across the Globe. Presspart's ability to offer customers a unique service in toolmaking, design and development skills has been the foundation for more than four decades of successful … read more

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