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Founded in 1976, Simbec Research is one of Europe's premier niche contract research organisations specialising in increasingly complex early clinical studies for the international pharmaceutical and biopharmaceutical industries.

Simbec is one of Europe's foremost CROs with over 35 years' experience in clinical drug development specialising in healthy volunteer and patient volunteer studies (Phase I-IIa). Simbec is a part of the Altasciences Group which means that as well as having laboratories in South Wales, United Kingdom, it also has facilities in Quebec, Canada. Combined facilities offer over 300 beds and an extensive volunteer and patient database.

Simbec have GCP, GLP, GMP and CPA Accreditation. We also have Standard and Supplementary MHRA Accreditation, meaning that as an Investigator Centre we are able to carry out clinical trials with compounds at all levels of risk, including those that require review by an Expert Advisory Group (EAG).

Simbec Clinical Pharmacology Unit (CPU) has extensive experience in conducting and managing safety, tolerability and pharmacokinetic studies, New Chemical Entity (NCE), First into Man, Proof of Concept, radiolabelled, bioavailability and bioequivalence studies, single and multi dose and short and long term studies.

Sygnature Discovery is a leading United Kingdom-based provider of integrated drug discovery services to the global pharmaceutical industry. Key areas of expertise include medicinal and synthetic chemistry, computational chemistry and bioscience. Sygnature´s team of more than 50 industry-experienced scientists add considerable value to our clients´ programmes by undertaking key elements of the drug discovery process, such as hit finding, hit-to-lead, lead optimisation and complete integrated drug discovery projects.

Services on offer at Sygnature include:

• Medicinal Chemistry
• Synthetic Chemistry
• Computational Chemistry
• Bioscience (in vitro biology and screening)
• Arrays and Libraries
• Process and Scale-up Chemistry
• ADME/Toxicology (via a strategic alliance with Cyprotex Discovery)

The ERA Consulting Group is one of the longest established and most experienced regulatory affairs and product development consulting groups serving the biopharmaceutical industry.  

Our expertise covers quality, nonclinical and clinical aspects, both from the regulatory and development strategy perspective. ERA has the knowledge and experience to assist from conception to registration, and beyond.

ERA has experience with a wide range of products (over 450 to date), including 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. ERA also works with innovative new chemical entities, particularly those indicated for neurological, oncological and immunological diseases.

Our specialised international team of more than 30 full-time 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 currently has four office locations (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.

Contact details:

Mr. Tristan Elliott

Business Development Manager

Tel: +44(0)20 7510 0200

Email: tristan.elliott@eraconsulting.com

Web: www.eraconsulting.com

Astex Pharmaceuticals™ is a leader in innovative drug discovery, development and commercialization, committed to the fight against cancer and other life-threatening diseases.

• Fiscal strength with significant cash, ongoing revenues and potential milestone payments
• Productive partnerships with top-tier pharmaceutical companies
• Rich product portfolio with multiple drugs in clinical development
• Visionary leadership backed by a world-class management team

We are a leader in innovative small-molecule therapeutics with particular expertise in fragment-based drug discovery, the most important advance in discovery chemistry in the last 20 years. Our primary areas of focus are oncology and hematology.

We are a publicly traded pharmaceutical company with strong cash reserves and royalty revenues from the sales of our product DACOGEN®. In addition, our partnerships could deliver nearly $2 billion in product milestones plus royalties.

prmaconsulting offers best-in-class strategic and operational Pricing & Reimbursement, Market Access and Health Economics advice. We work for the majority of the top 15 Big Pharma companies, as well as in Biotech and Medtech.

Fusion Antibodies is a world leader CMO in Antibody Sequencing; Antibody Engineering & Humanization and Expression and Purification of Pre-Clinical Grade Therapeutic & Diagnostic grade Proteins and cGMP scale up.

Eden Biodesign is an integrated biopharmaceutical development organisation and part of Watson Pharmaceuticals, Inc. (www.watson.com). Eden Biodesign is designated as Watson’s Centre of Excellence for Biologics, delivering process and product development; cGMP manufacturing and quality/regulatory expertise from a custom-designed facility located in Liverpool, UK.

Founded in 1976, Simbec Research is one of Europe's premier niche contract research organisations specialising in increasingly complex early clinical studies for the international pharmaceutical and biopharmaceutical industries.

Simbec is one of Europe's foremost CROs with over 35 years' experience in clinical drug development specialising in healthy volunteer and patient volunteer studies (Phase I-IIa). Simbec is a part of the Altasciences Group which means that as well as having laboratories in South Wales, United Kingdom, it also has facilities in Quebec, Canada. Combined facilities offer over 300 beds and an extensive volunteer and patient database.

Simbec have GCP, GLP, GMP and CPA Accreditation. We also have Standard and Supplementary MHRA Accreditation, meaning that as an Investigator Centre we are able to carry out clinical trials with compounds at all levels of risk, including those that require review by an Expert Advisory Group (EAG).

Simbec Clinical Pharmacology Unit (CPU) has extensive experience in conducting and managing safety, tolerability and pharmacokinetic studies, New Chemical Entity (NCE), First into Man, Proof of Concept, radiolabelled, bioavailability and bioequivalence studies, single and multi dose and short and long term studies.

Penn services include: CMC Consultancy, Formulation Development, Analytical Development, Clinical Trial Supply, Contract Manufacturing, Qualified Persons Release Services, Paediatrics Formulation and Manufacturing, Hi-Potency capabilities, Orphan drug expertise, More than 30 Years of specials, manufacturing expertise, Comparator Sourcing.

The above offerings are all under one roof providing a strong and easy communication channel between departments making developments, manufacturing and analytical processes.