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Harlow, UK, 5th May 2017On 2nd May 2017 the EMA and ...

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The European Medicines Agency (EMA) will launch a pilot project in February 2017 to tes...

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Response to the UK's Withdrawal from the EU


Harlow, UK, 5th May 2017On 2nd May 2017 the EMA and European Commission published a notice alerting Marketing Authorisation Holders of centrally authorised medicines of their obligations in relation to Brexit.1 Although the final d...

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EMA launches new pilot to support development of biosimilars


The European Medicines Agency (EMA) will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars w...

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Diamond Pharma Services at Phacilitate 2017


Will you be attending Phacilitate Leader's Forum in Miami on the 18th? Stop by booth 135 and have a chat with Diamond Pharma Services about your regulatory affairs requirements. Diamond Pharma Services will be attending this year's Phacilitate Lead...

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Brexit: Business as usual for Diamond Pharma Services


EU Referendum Result: Business as usual for the Diamond Pharma Services group of companies

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Diamond achieves first PRIME acceptance in Europe


Diamond achieves first PRIME acceptance in Europe on behalf of gene therapy client

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How ready are you for the new e-cigarettes legislation?


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The PRIME Scheme


In a previous post, the Adaptive Pathways Pilot was discussed, which is the EMA’s attempt to improve timely access for patients to new medicines by encouraging early dialogue betw...

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Maureen Graham wins TOPRA Futures Award


The 2015 TOPRA Awards for Regulatory Excellence This year, TOPRA (The Organisation for Professionals in Regulatory Affairs) hosted the Awards for Regulatory Excellence in the marvellous setting of the Royal College of Obstetrics and Gynaecology in ...

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Outsourced Regulatory Consulting: Case Studies


There has been a growing market in the provision of out-sourced services to meet the demands of lean (bio)pharmaceutical operations. The provision of advice and support in the regulatory activities required to support a clinical development programme is well suited to an outso...

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Regulatory Harmonisation between US and EU


It may not come as a surprise that even with the efforts of groups such as the International Conference on Harmonisation (ICH); who work on the harmonisation of regulatory standards between international regulatory bodies; a lack of regulatory consistency remains.The US...

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