Regulatory Affairs

We provide bespoke solutions to meet the regulatory affairs needs of our clients, whether it be ad hoc support for an urgent project need, or a long term strategic programme to deliver regulatory excellence with an experienced outsourced team.

 

Our team provides end-to-end regulatory affairs services and expertise-driven product development advice from the early stages of development through to post-market support.

 

Development Stage Regulatory Affairs Support

Taking a product from the lab bench, towards clinical development and into patients takes years of expertise, effort and expense. At Diamond we share our client’s passion to transition products towards the clinic and we excel in building regulatory considerations into product development programmes. We do this by helping our clients with:

  • Development plans and gap analysis
  • IMPD / IND / Investigator’s Brochure writing
  • Technical CMC regulatory expertise
  • Orphan applications, PIPs, PRIME
  • National and EMA scientific advice

We strive to stay at the forefront of regulatory science and we hold a leading position in providing regulatory affairs support to Advance Therapy Medicinal Products (ATMP) for cell and gene therapy programmes. Diamond supported the MAA submission for Glybera the first approved gene therapy product in Europe. We have since built significant experience in supporting over 30 different ATMP programmes including the EU regulatory programme leading to the approval of the CAR-T product Yescarta®. We also have broad experience across all molecule types including advanced biologics and small molecules.

 

Clinical Trial Applications

As a boutique consultancy we have developed expertise in the strategy and submission of Clinical Trial Applications (CTA) for a broad range of product types. We also have current experience for the evolving national requirements in the field of cell and gene therapy. The services we offer include:

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

We manage the CTAs for a diverse range of clients, from biotech companies running a single trial, through to pharma companies with more than 30 new applications per year and a large volume of substantial amendments.

 

Licensing and Publishing

At Diamond we provide a broad range of licensing, publishing and allied services across all stages of development and in the post market setting. We provide support in the following areas:

  • Assistance with all EU submission procedures
  • Dossier reviews & gap analyses
  • eCTD compilation: EU MAAs, US FDA INDs, NDAs & BLAs and post-approval submissions
  • Preparation of non-clinical and clinical overviews and summaries
  • Preparation of quality overall summaries
  • PIL user testing
  • E-liquids and TPD Notifications
  • Conversion of NtA dossiers into CTD and preparation of eCTD baselines
 

Post Market Regulatory Affairs Support

Our regulatory team are experts in the life cycle regulatory affairs needs for all product types including solid oral dosage forms, sterile parenterals, locally-applied, locally-acting products (such as creams, ointments & eye drops) and hormonal products. We provide the following services:

  • Dossier preparation
  • Life-cycle management of National, Mutual Recognition, Decentralised, and Centralised Procedures from preparation of initial MA applications through to full post-approval support and variations
  • Outsourced Regulatory Affairs Department
  • Regulatory Strategy
  • Overflow Regulatory Affairs Department
  • Training
Case Study

ATMP 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

Development Support

The Regulatory Development Department at Diamond Pharma Services has extensive experience in assisting companies to navigate through clinical development.

Case Study

European regulation of ATMPs1

European regulations concerning the development of Advanced Therapeutic Medicinal Products (ATMPs) are complex and provide a number of additional challenges to sponsors developing gene therapies, somatic cell therapies and tissue engineered products.

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

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.

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.