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Diamond Pharma Services is a leading technical services and consulting group, providing expert support and advice to pharmaceutical and biotechnology companies. Through analysis, interpretation and distillation of data, Diamond Pharma Services helps obtain and maintain medicinal product licenses across all stages of a product’s life cycle.
The company focuses on three core areas:

Regulatory

Pharmacovigilance

Compliance

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Regulatory

Pharmacovigilance

Compliance

Regulatory

Our regulatory division are experts in all aspects of EU regulatory affairs and provide support in the areas below. Of note the team have extensive experience in the field of cell and gene therapy and we excel in providing outsourced regulatory department services for companies of all sizes.

REGULATORY

Variations, MRP, DCP, Centralised
Outsourced Regulatory Department
Regulatory Strategy
Overflow Regulatory Department
Training
BREXIT Planning

CLINICAL DEVELOPMENT

Development plans and gap analysis
IMPD / IND writing
Technical CMC regulatory excellence
Orphan applications, PIPs, PRIME
Small molecule, biologics and ATMP experience
National and EMA scientific advice
US team and associated services

LICENSING

Gap analysis and strategy
EU MAA – National, Mutual Recognition, Decentralised and Centralised
NDA / BLA
Dossier preparation
eCTD

CLINICAL TRIAL APPLICATIONS

Competent authority submissions
Document authoring and coordination
GMO applications
CTA project management
Ethics submissions

Pharmacovigilance

The pharmacovigilance division are experts at all stages of EU clinical development and post market monitoring. Our service is complemented with an industry standard ArisG database and 24h monitoring support. The team are experts in Pharmacovigilance training and auditing. The company offer a full range of Pharmacovigilance documentation activities: Standard Operating Procedures (SOPs), Summary of Pharmacovigilance Systems (SPSs), Risk Management Plans (RMPs), Clinical Trial Annual Safety Reports (ASRs), Named patient / compassionate use program Annual Safety Reports, Periodic Safety Update Reports (PSURs).

POST MARKETING PHARMACOVIGILANCE

Drug Safety Project Management
Collection and follow-up of Adverse Drug Reactions (ADRs) Electronic management of ADRs
EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight
Reconciliation with Medical Information
Compliance oversight
Signal Detection

CLINICAL TRIAL PHARMACOVIGILANCE

Drug Safety Project Management
Collection and follow-up of Serious Adverse Events (SAEs) from clinical trials
Expedited reporting to Competent Authorities, Ethics Committees and investigator sites
Responsible Person for Eudravigilance oversight
Reconciliation with clinical database
Eudravigilance set up and management
Signal Detection

MEDICAL DEVICE VIGILANCE

Device Vigilance Project Management
Collection and follow-up of Medical Device Incidents
Weekly literature searches of Medline
Electronic management of Incidents on the ARISg database
Expedited reporting of Medical Device Incidents to Competent Authorities
Distribution of Field Safety Corrective Actions and Field Safety Notices

Named-Patient and Compassionate Use

Drug Safety Project Management
Collection and follow-up of Adverse Events (AEs) from named patient and compassionate use programs
Weekly literature searches of Medline
Electronic management of AEs on the ARISg database
Electronic expedited reporting to Health Authorities
Eudravigilance set up and management
EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight

Compliance and Quality

Our compliance and quality division provides expert QP led services to pharmaceutical companies worldwide. The team excels in providing support for product lifecycle management, vendor management, supply chain compliance and auditing

Products entering the EU

EU QP and batch release provision.
Global Site Audits including API, Batch release, QC and Importation, Finished product & primary and secondary packaging.
EU technical agreements and agreements between EU-UK, UK-EU.
EU GMP Inspection readiness.
EU Falsified medicines directive planning.

UK based products

UK QP and batch release provision.
UK Audits.
UK technical agreements
UK GMP inspection readiness.
UK MIA/WDA applications and variations

Qualified & Responsible Persons Services

Provision of contract QP services in compliance with EU Directives for the manufacture and release of finished pharmaceuticals and GMP.
QP services for the batch release of IMPs for clinical trial.
Provision of contract RP services in compliance with EU Directives for the wholesaling of medicinal products and GDP.
RP services for quality defects and product recalls of your Marketing Authorisation (MA) applications.

General Services

General cGMP Compliance Audits
Quality Systems Review
Quality Validation activities
Product Development and Regulatory Compliance
All aspects of Quality Training
Computer System Audits
Regulatory Inspection Preparation
Product lifecycle management

EXPERTISE

Our staff are experts in EU regulatory, pharmacovigilance, compliance and quality. Diamond Pharma Services has three offices in continental Europe and is well placed to provide continuity of service regardless of the outcome of the Brexit negotiations. See our page dedicated to an ongoing appraisal of the negotiations and for details of our Brexit solutions.

In the US we have a collaborative network of providers to assist companies in the navigation between EU and US regulatory pathways.

Brexit updates

News

News articles

Locations

Diamond Pharma Services has established a network of offices to provide a broad range of integrated services. Click below for further details.

Harlow, UK

Cambridge, UK

London, UK

Europe

Harlow, UK

Our global headquarters are housed in state of the art facilities in Harlow UK at the heart of the Cambridge-Stansted-London (M11) corridor. The office is a 2 minute walk from Harlow railway station and is a 15 minute rail journey from Stansted Airport and 35 minutes from London Liverpool Street station.

Cambridge, UK

Our satellite office is based on the Cambridge Science Park offering a vibrant location that is walking distance from the Cambridge North railway station.

London, UK

Our London office is accessible to a wide geographical area with a world class pool of talent.

Europe

Our EU headquarters are based in The Netherlands at Amsterdam Zuid close to the future home of the European Medicines Agency. The legal entity Diamond Pharma Services B.V. ensures business continuity through Brexit and offers continued growth for the organisation into continental Europe.

Further offices in Barcelona and Sofia support our growing presence in mainland Europe.

US

Diamond Pharma Services Inc is based in Boston and is central to our growing collaborative partnerships with consultancies and independent consultants to provide a broad range of capabilities.

Contact us

Please contact us for more details about our world leading services and our business development and operations team will provide answers to your questions.

Global Headquarters

Diamond Pharma Services
Suite 2
Ground Floor
Field House
Station Approach
Harlow
Essex CM20 2FB
United Kingdom

London UK

Unit 214,
Burford Road Business Centre
11 Burford Road
Stratford
London E15 2ST
United Kingdom

Cambridge UK

Suite 55, Innovation Centre
Cambridge Science Park
Milton Road
Cambridge CB4 0FN
United Kingdom

EU Headquarters

Full details to be released in February 2018.

info@diamondpharmaservices.com
+44 (0) 203 911 9410

For Business Development Enquiries, please contact:

Post-Market and Generics

ldemetre@diamondpharmaservices.com
+44 (0) 7876 664 543

Clinical Development Stage

rdavis@diamondpharmaservices.com
+44 (0) 7586 441 663