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Acorn Regulatory News

Post Authorisation Safety Studies - Acorn Regulatory

Post Authorization Safety Studies – An Important Tool in PV

Post authorisation safety studies (PASS) are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine […]

TOPRA Symposium 2019

TOPRA Symposium 2019 – Come & Meet Us

The TOPRA Symposium 2019 will bring over 700 regulatory professionals to Dublin, Ireland to hear from a wide range of […]

Dekra has been chsoen as the 3rd notified body accredited under MDR

DEKRA Chosen As 3rd Notified Body Under MDR

DEKRA, the German based company, has been chosen by The European Commission as the third notified body to be accredited […]

What Are The Key Factors To Consider When Planning To In-Licence An eCTD Dossier?

In this article we are taking a look at 4 key factors to consider when planning to in-licence an eCTD […]

2019 Pharma Awards Finalist Acorn Regulatory

2019 Pharma Awards Finalist – Acorn Regulatory Shortlisted

Acorn Regulatory has been shortlisted at the 2019 Pharma Awards in the Pharma Contract Services Company of the Year category. Founded […]

How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple […]

MRP Grouped Variations

What You Need To Know About MRP Grouped Variations

Previously, we have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations […]

What is KASA FDA

KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application

What is KASA and how will it impact on getting a drug assessed by the US FDA?  In this article we […]

No Deal Brexit Planning from Acorn Regulatory

No Deal Brexit Planning – What We Know So Far

The ongoing coverage of the UK’s moves towards leaving the European Union continues.  This is a difficult time for companies […]

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