Rightqa.Dk

rightQA.dk is a consulting company helping pharma and biotech companies. We specialize in the quality processes and the development process. We can also assist in organization and re-organization of the Quality area. With more than 30 years’ experience in the industry, including big pharma, mid-size pharma, small biotech and medical devices, rightQA.dk can guide you safely through the regulation. AUDITS, INSPECTIONS, DUE DILIGENCES AND QUALITY ADVICE rightQA.dk perform both internal and external audits, as well as Due Diligences. With experience from authorities from all over the world, we can help you prepare for- and participate in authority inspections such as FDA and EU. We give professional advice, sparring or second opinion about quality cases and risk evaluations. QUALITY AGREEMENTS AND DOCUMENTS We help to develop and negotiate the quality agreements with your partners. We also offer solutions in the intersection between quality, CMC and regulatory. With practical experience from development and Quality, rightQA.dk can help you with documents and practical solutions like filing a new product, or during the development process. QUALITY SYSTEMS AND IT SYSTEMS rightQA.dk can help with development of Quality Metrics and Quality Management Reviews. This will give you the right KPI’s and facts for compliance, that in turn gives an overview of the high level compliance status in your company. We can also check your quality systems and come up with proposals for improvement and efficiency. Furthermore, we offer coordination of validation and implementation of IT-systems. QUALITY ORGANIZATION DEVELOPMENT AND LEAN IN QUALITY With years of experience from organization and re-organization of Quality organizations, including cooperations with McKinsey, rightQA.dk can help to create an effective Quality organization in your company. We work with LEAN tools, which we customize to be more suitable and more effective for the Quality area.