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PASM offers clinical trial support services, with special expertise in helping SMEs. Projects undertaken span planning a clinical trials program to meet a regulatory strategy, through to designing and implementing outsourcing strategies to fit the company's needs.
With a portfolio of more than 3,000 products covering the fields of genomics, protein analysis and expression, cellular analysis, drug discovery and genetic identity, Promega is a global leader in providing innovative solutions and technical support to life scientists in academic, industrial and government settings.. Promega products are used by life scientists who are asking fundamental questions about biological processes as well as by scientists who are applying scientific knowledge to diagnose and treat diseases, discover new therapeutics, and use genetics and DNA testing for human identification.. . Promega holds significant intellectual property rights and licenses in several key areas that form a foundation for its diverse portfolio including:. •
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Protogenia Consulting Ltd offers non-clinical and early clinical development consultancy services, with more than 15 years' outsourcing and project management experience gained through virtual and mid-sized pharmaceutical companies. The services offered include: strategic planning to enable early clinical development and product registration; non-clinical and clinical project management; regulatory submission writing/review/sign-off (e.g. CTA/IND, MAA/NDA, IMPD and IB); and CRO selection and study management – clinical (up to Phase 2) and non-clinical (toxicology, safety pharmacology, ADME, bioanalysis). In addition, we have a broad network of contacts, for expert advice on IP, CMC, analytical services, regulatory affairs and quality assurance.
QRC Consultants, experienced professionals dedicated to providing high quality, cost-effective support to biopharmaceutical companies in early clinical development. We offer technical expertise with strengths including: understanding of the regulatory environment governing clinical trials globally; regulatory agency meetings and submissions – trial management, and monitoring and audit of trials; and small molecules, biological and advanced therapies. Services include: quality assurance – setup and maintenance of QMS, GCP audits and agency inspection preparation; regulatory affairs – technical document writing, SME and EU legal representative services, and bespoke procedural and GCP training; and clinical trial support – project management and monitoring.
The Quadram Institute is an interdisciplinary research centre capitalising on the academic excellence and clinical expertise of the Norwich Research Park. Its mission is to understand how food and the gut microbiota link to the promotion of health and the prevention of diet and age-related diseases. It brings together fundamental and translational science with a clinical research facility for human trials and one of Europe’s largest gastrointestinal endoscopy units. The Quadram Institute is accelerating innovation by synergising interactions between basic and clinical research, delivering a step-change in the understanding of the role of food and the microbiome on health.