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 Department Overflow
Maintaining a headcount balance in regulatory affairs departments in the pharmaceutical industry is a perennial headache for any senior management team.
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.
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.
Compliance And Quality Division
Diamond Pharma Services offers GMP and GDP compliance services from clinical development to commercial distribution of the products’ lifecycle.
Development Support
The Regulatory Development Department at Diamond Pharma Services has extensive experience in assisting companies to navigate through clinical development.
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.
Diamond chairing a session at the 18th Regulatory and Scientific Affairs Conference
Nick Littlebury will be chairing a session at the 18th Regulatory and Scientific Affairs Conference on the topic of Brexit
Read articleMHRA: Hard Brexit transfers for centrally authorised products
MHRA contact marketing authorisation holders to give further details about the automatic transfer of Centrally Authorised Product Licenses into UK License
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LET DIAMOND TAKE CARE OF YOUR TO DO LIST Diamond Pharma Services comprises three divisions that provide cutting-edge…
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Any pharmaceutical company wishing to hold EU licenses must have a legal entity registered within Europe.…
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All EU marketed products will need to be registered with a legal entity in the EU. To meet the requirements post-Brexit…
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