First Gene Therapy eCTD

Diamond BioPharm Limited, announce a cutting edge first. As well as the submission of a Marketing Application for a Gene Therapy Product in December 2009 - on behalf of Amsterdam Molecular Therapeutics, a leading company in the development of gene-based therapies - the dossier is also in eCTD format. Maureen Graham, founder of Diamond BioPharm Limited said that it was a major achievement for both companies and is both proud and honoured that Diamond BioPharm Limited has had an opportunity to be part of this innovative project.

Important facts:

eCTD Gene Therapy Product Submission from UK company

• DOSSIER - 3 years in the making, researching the development and regulatory requirements for an advanced therapy, writing complex modules.
• CO-OPERATION - more than 3 years working closely with the overseas client - no or new guidelines to work around for an advanced therapy
• ADAPTING - as the Regulatory guidelines progressed
• WORKING - hand in hand with the scientists
• LIAISING - with Regulators in an ever advancing field
• PROVIDING - strategic advice and leadership throughout serving as the Regulatory function.
• eCTD - 6 months to find the right format, installation, I Q,OQ,PQ validation.

• • Using structured template to create the perfect format
  • Instructing/training on dossier format.
  • Ensuring consistency of documentation
  • Collating modules for input and hyper-linking
  • Complex tracking system to ensure every document uploaded
  • Full quality control assurance
  • Successful pilot test with the Regulatory Authority
  • Deadline 24th December and we did it with 24 hours to spare

Notes to editors
Diamond Pharma Services is a group of companies which provides out-sourced support solutions in Europe for pharmaceutical companies and which comprises Diamond BioPharm Limited (Regulatory), Diamond PV Services Limited (Pharmacovigilance & Medical Information), Diamond Compliance Limited (Quality), Diamond Clear PILs Limited (PIL User Testing) and Diamond IT Services Limited (Technical Support). The founder of Diamond Pharma Services, Maureen Graham, founded the first Diamond company –Diamond BioPharm Limited – in 2005. Diamond Pharma Services is a privately owned organisation.

Website: www.diamondpharmaservices.com

For further information please contact: David Page, Mulberry Advertising

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