Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersIndustry NewsMDRPharmaceuticalPharmacovigilance
How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies
Life science companies face considerable challenges aside from developing and launching new medicinal products and medical devices. The consistent pace of change means that companies must maintain understanding of developments in the sector. In this article, we look at some...
10 Questions You Need To Consider When Moving from A DCP Close Out To Product Launch
When a Decentralised Procedure (DCP) or a Mutually Recognised Product (MRP) process is drawing to a close, much of the emphasis is placed on the getting a “positive opinion”. However, it is at a time like this, when submitting the...
Case Study: How To Obtain A Certificate of Suitability (CEP)
We worked with a major US manufacturing firm to obtain a CEP. Our team worked closely with the manufacturing company to ensure that the project was completed as efficiently as possible. Recently, the client contacted us to say “Our CEP...
Acorn Regulatory NewsEventsGemma RobinsonIndustry NewsPharmaceuticalQuality Management SystemRegulatory Affairs
HPRA Seminar on MAH Regulatory Compliance Inspection & Advertising Compliance Programmes
Acorn Regulatory staff were among the members of a capacity audience at the HPRA seminar on MAH regulatory compliance inspection and advertising compliance programmes that was held at the Hilton Dublin on November 27th 2017.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
How To Develop A Regulatory Strategy: An Overview
The old adage ‘failing to plan is planning to fail’ could not be any truer when considering your regulatory strategy. A carefully crafted regulatory strategy is crucial when a pharmaceutical company wishes to market its medicinal product across regions subject...
Life Science Trends 2017 Event in Cork on November 15th
Experts from Acorn Regulatory will be among the guest speakers at the Life Sciences Trends 2017 Conference in Little Island in Cork on November 15th next.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceutical
Type I Variation: Apparently Not So Simple
In response to queries from regulatory professionals, we asked one of our regulatory experts to provide an overview of a Type I variation. In this article, we look at the common validation issues, what to look for in relation to...
NTK: Need To Know- 5 Pharmacovigilance Articles You Must Read
We produce hundreds of thought leadership pharmacovigilance articles on our site and in publications each year. Here are just 5 pharmacovigilance articles that you might have missed and that you should read.
Are You Ready for the Falsified Medicines Directive?
The Falsified Medicines Directive (FMD) was published in 2011 with the aim of preventing falsified medicines from entering the pharmaceutical supply chain in the European Economic Area. Conformity with the FMD will be required from February 9th, 2019 next.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
5 Steps To Obtain A Wholesale Distribution Authorisation Licence
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. Here, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
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