Pharmora Limited was established in 2010. We provide medical and scientific expertise to support key areas of global pharmacovigilance and clinical research support including defined deliverables, flexible resources and training of internal client personnel. We have built a strong reputation by delivering high quality services in order to support our clients to achieve their goals. Pharmora has experience supporting clients through the entire clinical development process, through submission of marketing authorisation applications, the regulatory review process and beyond. Activities include protocol development, data review in preparation for key study milestones or governance interactions during clinical development, submission and inspection-readiness activities towards the end of pivotal clinical studies and support for regulatory interactions during the review period. Pharmora also has safety expertise and has supported clients in managing review and documentation of safety data including signal evaluations and preparation of Periodic Benefit-Risk Evaluation Reports (PBRERs) in addition to Development Safety Update Reports (DSURs). Pharmora supports clients in the production of Briefing Documents, Risk Management Plans (RMP/REMS), integrated safety and efficacy summaries, clinical overviews and the Company Core Data Sheet (CDS). Pharmora medics and scientists have expertise in clinical development and pharmacovigilance ranging from safety scientists to EU QPPV level and global strategic leads. Clients of Pharmora have ranged from large global pharmaceutical companies to academic institutions such as the Drug Safety Research Unit and a number of research organisations formed within University R&D departments. The CMO has served on the steering committees for several industry/academic collaborations. Areas of expertise range from post-marketing safety evaluation for established therapeutics to early development of new chemical entities or biologicals. Products supported by Pharmora to date include vaccines, cytokines, immuno-oncology, biosimilars, generics, novel combinations, nutritionals and medical devices.