World Quality Week
QA+ are celebrating World Quality Week from 8-12 November 2021 along with likeminded organisations from around the world.
Coronavirus: What’s it like to start a new job when working remotely?
Meeting your new team and being shown round the office is one of the biggest parts of starting a new job. But how does it feel when everyone is working from home? Meet our Quality Officer Luke Brobyn who did exactly this.
Countdown to the End of the Transition Period
On the 1st January 2021 the UK will no longer be in the EU single market and customs union. Following on from our post about the possible UK eCTD publishing requirements in a post-Brexit world, our next regulatory topic is the anticipated post-transitional arrangements of medicinal products approved via
Deadline Looms for the Safe Labelling of Excipients in Medicines
In October 2017, the EMA and European Commission updated the annex to excipient guidelines for new safety advice of 15 excipients and the three-year timeline to implement the change is nearly over. Excipients are considered to be the ‘inactive’ substances in the medicinal product that are added in addition the drug substance
Brexit Strategy Legal Presence Requirements in UK
Legal presence requirements in UK The transition period was not extended at five minutes to midnight on 30 June 2020. In theory the UK and EU may negotiate an agreement which means that all the previously published MHRA requirements listed for a “no deal” Brexit may not be needed at the end of the
Making sense of the regulatory landscape in the UK and Europe
This year marks the 10-year anniversary since eCTD became mandatory for all submissions to the EMA for Centrally Authorised Products, meaning all these products have eCTDs hosted by the EMA. After the transition period on the 31st December 2020, the MHRA will not be able to access these eCTDs anymore, meaning new baseline sequences will
Variations
QA+ can assist you with compiling the necessary data and making variations to maintain the lifecycle of your product, we can help through an end to end submission or by providing advice and guidance to help you keep your medicine complaint and on the market.