Diamond Pharma Services is a leading technical services and regulatory affairs 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 licences across all stages of a product’s life cycle.
The company focuses on three core areas:
EXPERTISE
Our staff are experts in EU regulatory affairs, pharmacovigilance, compliance and quality. Diamond Pharma Services has two offices in continental Europe and is well placed to provide continuity of European service, our core skill set, regardless of the outcome of the Brexit negotiations. CLICK HERE to see our page dedicated to an ongoing appraisal of the negotiations and for details of our Brexit solutions.
To provide a global solution, we have a collaborative network of US providers to assist companies in the navigation between EU and US regulatory pathways.
Regulatory Affairs
Our regulatory affairs staff provide a full range of regulatory services from strategy through to outsourced regulatory departments.
- Development stage regulatory affairs services
- Clinical trial applications
- Licensing
- Post market and lifecycle regulatory affairs support
Pharmacovigilance
Comprehensive outsourced pharmacovigilance department services ensuring compliance throughout the product life cycle. A bespoke and scalable service to meet the needs of your company.
Pharmacovigilance
Compliance and Quality
Full service quality assurance and Qualified Person activities from product concept to market and beyond.
- Qualified Person and Responsible Person services
- Product life cycle management
- Audits and inspections
Case Study
Regulatory Department Overflow
Maintaining a headcount balance in regulatory affairs departments in the pharmaceutical industry is a perennial headache for any senior management team.
Case Study
ATMP (Cell and Gene Therapy) Regulatory Support
The team at Diamond Pharma Services has world class regulatory experience in assisting companies developing advanced therapy medicinal products (ATMPs). Support can be provided for both cell and gene therapy products for Europe and the US.
Case Study
Clinical Trial Application Service
The CTA team at Diamond Pharma Services is integrated into the Regulatory Development Department. The team has extensive experience in CTA activities for a wide range of product types.
Case Study
Compliance And Quality Division
Diamond Pharma Services offers GMP and GDP compliance services from clinical development to commercial distribution of the products’ lifecycle.
Case Study
Development Support
The Regulatory Development Department at Diamond Pharma Services has extensive experience in assisting companies to navigate through clinical development.
Case Study
Outsourced Regulatory Department
Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team.
MARCH 22, 2019
Diamond support Akcea in Waylivra MAA
Diamond Pharma Services supports Akcea Therapeutics in gaining EU regulatory approval for WAYLIVRA treatment for familial chylomicronaemia syndrome (FCS)
Read articleFEBRUARY 26, 2019
CAR-TCR Summit - Yescarta Case Study
Maria Fernandez presented today as part of the Yescarta Case Studies session at the CAR-TCR Summit Europe (Hammersmith, London).
Read articleResources
31 July 2019Case Studies
The team at Diamond Pharma Services has world class regulatory experience in assisting companies developing advanced…
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08 November 2018White Papers
LET DIAMOND TAKE CARE OF YOUR TO DO LIST Diamond Pharma Services comprises three divisions that provide cutting-edge…
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24 October 2018Brexit
Any pharmaceutical company wishing to hold EU licenses must have a legal entity registered within Europe.…
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