Regulatory Affairs

Diamond Pharma Services and ERA Consulting


Diamond Pharma Services

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Diamond Pharma Services is a leading technical and scientific consulting group of companies serving the biotechnology and pharmaceutical industry. Our emphasis is on the following areas:

  • Regulatory Affairs: From Product Concept to Registration and Beyond
  • Product Development: Nonclinical, CMC and Clinical Aspects
  • Pharmacovigilance: Clinical trial (Phase I-IV), Post-Marketing and QPPV Services
  • Compliance: GLP, GMP, GCP and QP Services
  • Patient Information Leaflet Testing: Over 120 Tested with 100% Positive Agency Feedback

Our clients range from virtual start-up companies to the largest multi-national corporations. Our expertise includes products of recombinant DNA and hybridoma technology, nucleotide based products (RNA and DNA), synthetic peptides, chemical entities (innovative and generic), vaccines (therapeutic and prophylactic), blood products and advanced therapy medicinal products (gene therapy products).

We have sophisticated and well-equipped office facilities and a state-of-the-art IT system. Our IT system includes a fully validated in-house eCTD system (Extedo) and safety database (ARISg). The group was founded in 2005 by Dr. Maureen Graham, formerly Director of Regulatory Affairs at Amgen. Our specialised team of more than 24 professionals includes those with a broad and varied industry experience and former regulators, offering both breadth and depth of expertise, from which our clients can benefit.

How we can help
Diamond Pharma Services can provide expert consulting services in the following areas:

  • Regulatory Affairs: From Product Concept to Registration and Beyond
  • Product Development: Nonclinical, CMC and Clinical Aspects
  • Pharmacovigilance: Clinical trial (Phase I-IV), Post-Marketing and QPPV Services
  • Compliance: GLP, GMP, GCP and QP Services
  • Patient Information Leaflet Testing: Over 120 Tested with 100% Positive Agency Feedback

Our offering to LBIC Clients
Prospective LBIC Clients: Support with regards to the acquisition of new clients by LBIC. The focus of this will be to help explain the value of the Virtual Business Support Network and the services offered by Diamond Pharma Services.

Clients that have signed an agreement with LBIC: A free initial 2-hour strategy meeting or teleconference with key members of the Diamond Pharma Services team. This will be essential for defining the most efficient and productive strategy for progressing the development of the product. We would request that a CDA be signed before this interaction. This meeting will allow us to discuss any issues that you may have at this time. We would request that Diamond Pharma Services is provided with some background information and any specific questions in advance of the meeting to allow us to prepare sufficiently.

Continued Support: Diamond Pharma Services would be pleased to offer its services to LBIC tenants on an ongoing basis. As part of our offering we are pleased to provide our services at a discounted rate.


ERA Consulting Group

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ERA Consulting Group is one of the longest established and most experienced consulting groups serving the biopharmaceutical industry. Our emphasis is on consulting relating to quality, nonclinical and clinical aspects, both from the perspective of development strategy and regulatory requirements. Biopharmaceutical products and biomarkers are our particular speciality. 

How we can help
ERA has the knowledge and experience to assist at all stages of product development, from conception to registration, and beyond.

Our expertise covers a wide range of products (around 400 products to date), incorporating recombinant DNA and hybridoma technology, synthetic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products comprising gene therapy, somatic cell therapy and tissue-engineered products.

We also consult on innovative new chemical entities, particularly those indicated for neurological, oncological and immunological diseases. Last, but not least, the ERA team includes specialists for companion diagnostics and biomarkers, offering dedicated services in this cutting edge field.

Our team of more than 30 professionals includes scientists with a research and development background, those with extensive industry experience and former regulators, offering both breadth and depth of expertise, from which our clients can benefit.  ERA has office facilities in Germany, the UK, the USA and Australia, with the in-house capability to prepare documents and complete submissions on behalf of clients, including a dedicated eCTD group.

Our Offer to LBIC Clients
A free 2-hour strategy meeting or teleconference with key members of the ERA Consulting team. This will be essential for defining the most efficient and productive strategy for progressing the development of your product. ERA is pleased to offer its services to LBIC clients on an ongoing basis. As part of our offering we are pleased to provide our services to LBIC clients at a discounted rate.