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
Regulatory

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
Compliance
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.

 
Resources
08 November 2018White Papers

LET DIAMOND TAKE CARE OF YOUR TO DO LIST Diamond Pharma Services comprises three divisions that provide cutting-edge…


Download Resource
24 October 2018Brexit

Any pharmaceutical company wishing to hold EU licenses must have a legal entity registered within Europe.…


Download Resource
24 October 2018Brexit

All EU marketed products will need to be registered with a legal entity in the EU. To meet the requirements post-Brexit…


Download Resource
VACANCIES
VACANCIES

The ATMP Expert provides development stage advice to internal staff and to clients for a broad range of Cell and Gene Therapy programmes. They will possess a strong understanding of existing and leading-edge technologies, and is able to speak knowledgeably about client programmes.