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Diamond Biopharm is one of very few European regulatory companies which has experience in clinical and regulatory development programmes within the gene therapy sector, to an advanced stage of development. Its first European Marketing Authorisation Application submission for a gene therapy product will be in 2009.
The company was founded in 2005, by Maureen Graham. Formerly Director of European Regulatory Affairs at Amgen, Maureen has a huge amount of experience in the biotechnology field and was later engaged (as Diamond BioPharm Limited) to lead the regulatory development of a pioneering gene therapy treatment. Supported by an experienced team of regulatory experts, Diamond is now a leader in this field.
“Bridging the Gap … from invention to the market place”
What can Diamond BioPharm do for your Gene Therapy programme?
- Bring expertise and experience through direct project involvement
- Prepare high quality documentation to support Clinical Trial Applications (IMPD, IND, CTA)
- Links with North American regulatory specialists to support global development programme
- Manage regulatory dossier life-cycle from project initiation to submission, MA approval and beyond
- Assist with writing, editing and reviewing Modules 3, 4 and 5 of the CTD dossier
- eCTD-ready documentation and publishing
- Act as legal representative in the EU for clinical trials
- Be the central point for communication with regulatory agencies
- SME status means lower fees for Scientific Advice meetings and regulatory submission fees
Critical issues that Diamond BioPharm can assess and add value to the product development include:
- Comparability studies for changes in production processes
- Characterisation studies
- Viral safety evaluation
- Non-clinical …choice of animal models
- Germ line transmission
- Integration
- Environmental risk
- Clinical protocol design
- Risk management planning
- Pharmacovigilance
Examples of Diamond BioPharm Limited’s major successes
- Orphan Drug designation approvals
- Approval of Paediatric Investigation Plan
- Scientific Advice and Product Strategy meetings
- Successful Clinical Trial Applications in more than 20 countries
- 10+ Centralised Marketing Authorisation approvals
Diamond Pharma Services is a group of companies which provides technical support to the pharmaceutical industry, focusing on specialised services such as Regulatory, Quality and Drug Safety.
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