Diamond Pharma Services is a group of companies offering consulting services to support regulatory affairs and product development in the EU and US.

Diamond BioPharm Ltd provides consultancy services in European regulatory affairs and product development to the biotech and pharmaceutical industries. The company was founded in 2005 under the leadership of Dr. Maureen Graham (ex. Amgen, MSD, Glaxo & IVAX).

The team Dr Graham has established includes those with a broad and varied industry experience and former regulators, offering both breadth and depth of expertise, from which our clients can benefit. Our many years of industry experience and expertise is across a broad range of therapeutic areas and product types (biotechnology including monoclonal antibodies, gene-therapy and new chemical entities – both innovative and generics). The entire team has significant experience and knowledge of European regulatory procedures (national, mutual recognition, decentralised and centralised) and an in-depth awareness of current legislation and industry trends.

Diamond BioPharm consultants have extensive experience of assisting clients with regulatory support from early stages of product development through to achievement of marketing authorisations, orphan designations, scientific advice and have also assisted with the maintenance of marketing authorisations through variations, and monitoring and updating of prescribing information.

Diamond BioPharm Ltd was awarded TOPRA Innovation Award 2013 for supporting the first gene therapy product approval in Europe.

Diamond Pharma Services, Inc. provides consultancy services in US regulatory affairs and product development to the biotech and pharmaceutical industries. The company was founded in 2015 as a subsidiary of Diamond BioPharm Ltd. Diamond Pharma Services, Inc. consultants have extensive experience of assisting clients with regulatory support from early stages of product development and IND initiation through to achievement of marketing authorisations, orphan designations and successful FDA meetings.