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Benefits of Outsourcing Regulatory Affairs
The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA deal and the AMNOG deal in Germany) has caused companies to address internal issues and to seek to minimise the negative...
Find Out More About Acorn Regulatory’s Pharmacovigilance Services
Right now, we are working as the ‘virtual pharmacovigilance office’ for many of the most dynamic healthcare manufacturers in the world. They trust us to act on their behalf because of our long-held reputation and our commitment to service excellence....
Changes to ISO 9001
At Acorn Regulatory we are committed to ensuring quality in all aspects of what we do so it’s vital to us to stay informed of updates in legislation, requirements or standards in our field of expertise – quality and regulatory....
Industry Bodies Come Together To Host BioPharma Ambition.
Minister Simon Harris’ confirmation that the Irish government will soon be making a bid to be the new home of the EMA was one of the main talking points at the first BioPharma Ambition conference in Dublin.
Acorn Regulatory Monthly Newsletter: September 2016
We have just launched our new Acorn Regulatory monthly newsletter. You can read all of the stories from the newsletter here. If you are not already subscribing then sign up to receive the next edition.
The Implications of Brexit for the Life Sciences Sector
The implications of Brexit are still being felt. Politically, the decision has triggered a chain of events that none of us could have ever foreseen. Now, with a new Prime Minister in Downing Street and three leading ‘Brexiteers’ appointed to offices...
Get The Industry News Roundup for September
In this month’s roundup of industry news roundup, we will be looking at how the USA and Canada are working to align their submission gateways to assist companies making regulatory applications. We will also look at a new EMA drug...
Implications of Brexit for the Medical Device Sector
In this extract from our first Brexit whitepaper, written in July 2016, we look at the implications of Brexit for the medical device sector.
EMA Introduces New Chapter on Good Pharmacovigilance Practices (EU-GVP)
The European Medicines Agency has added a new chapter (Product- or population-specific considerations II: Biological medicinal products) to its guidelines on good pharmacovigilance practices – EU GVP. The new GVP guidance comes into force on August 16th 2016. The new chapter...
Brexit Clinical Trials Sector Implications
In this extract from our first Brexit whitepaper we look at the implications of Brexit for the clinical trials sector.
