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2 years ago-Biopharma Group
2 years ago-BioGenes GmbH

Diamond Pharma Services

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Diamond Pharma Services are an EU focused regulatory affairs and product development consultancy.

Founded in 2005, Diamond are celebrating 15 years of excellence in EU regulatory affairs, providing support from early stage development through to life cycle management of approved products in all types of therapeutic areas. Our team of consultants have a wide range of experience and backgrounds within regulatory affairs and our senior consultants have over 100 years combined industry experience.

 

We provide bespoke solutions to meet the regulatory affairs needs of our clients, whether it be long term strategic programme to deliver regulatory excellence with an experienced outsourced team, or ad hoc support for an urgent project need.

 

Expertise in Cell and Gene Therapies – While Diamond support all therapeutics modalities, we have developed industry leading expertise working with advanced therapeutic medicinal products (ATMPs) such as cell and gene therapies. Diamond supported the EU development and marketing authorisation of the first gene therapy to ever receive regulatory approval, Glybera. Since then we have worked on over 50 advanced therapy programmes, including the European development program and marketing authorisation for the first CAR-T product approved in the EU, YESCARTA®.

 

Award winning – Diamond’s excellence in EU regulatory affairs has been recognised multiple times by the official industry body The Organisation for Professionals in Regulatory Affairs (TOPRA) with their prestigious TOPRA awards. Diamond have won awards in 2013, 2015 and twice in 2018.

 

In addition to regulatory affairs consulting, Diamond can also provide pharmacovigilance and quality & compliance services. We aim to always meet client need and expectations by delivering projects with transparency and continuous lines of communication.

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