R.A.Q.A. Associates, Inc., established in 1985, is located just North of Albany, NY. Our Associates provide FDA and ISO related consulting services to companies ranging from new ventures to Fortune 500 corporations across the US and internationally. We specialize in helping firms with regulatory and cGMP problems, constructing and implementing entirely new quality and regulatory systems or improving existing systems.
All of our Associates have had significant industrial careers before joining the R.A.Q.A. team. From their experiences on the inside of medical device and pharmaceutical firms they have learned the best practical approaches to FDA issues and requirements. They know what is the best solution from both an operational and cost perspective. Key senior positions held in industry prior to consulting include regulatory affairs, research and development, sterilization technology, device packaging, design and development, validation (software and process), compliance, quality assurance/control and clinical affairs.