R & C Consulting Group LLC

We are a team of knowledgeable and experienced regulatory affairs, clinical affairs, and quality system professionals eager and capable to help with advancing your medical device, biologic, in vitro diagnostic, pharmaceutical and combination products from conception to markets through the total life cycle. Our areas of expertise include: • Regulatory strategy (domestic and international), submission preparation and filing with US and worldwide Regulatory Authorities. • Clinical trials strategy and planning, management of clinical trials and analysis of results. • Quality system design, development, implementation and maintenance. • US and worldwide Regulatory Authorities relations and crisis management. • Total or selected Regulatory Affairs or Clinical Affairs Outsourcing, virtual Regulatory or Clinical Affairs Departments. • Health Economics Outcomes Research supported by market access modeling, budget impact modeling, evidence generation (epidemiological research, registries, supportive and historical clinical research), global value dossier development and reimbursement dossier submissions. Please, contact us: Irina Kulinets, PhD, RAC, CQE 617-823-0603 ikul@comcast.net