Regulatory Affairs, North America, Inc. (RANA) is a consortium of professionals founded by Nancy Chew, a well-known and widely respected expert in regulatory affairs. Ms. Chew and her colleagues are filling the need for a small, highly effective team of experienced specialists fluent in product development services for FDA regulated products. This team works on the philosophy of long-term relationships, unimpeachable integrity, and absolute top-level work. They have earned a reputation for flexibility, total project strategies and, above all, practical solutions to complex problems.
The RANA consortium comprises only professionals known personally through prior collaborations.
Our experience includes the development of small molecule pharmaceuticals and well-characterized proteins in all reviewing divisions of CDER, as well as complex regulatory projects including gene therapy and combination products.
RANA has longstanding relationships with European regulatory consultancies well placed to provide advice and liaison with local authorities and provide for local language requirements.
From technology transfer to first-in-human studies, to clinical characterization and marketing applications, Regulatory Affairs, North America has the expertise to move your products through FDA.
RANA offers consulting services to the pharmaceutical and biotechnology industries.
• Identify and prioritize strategic regulatory options
• Advise on US and European registration strategies
• Plan, rehearse, and conduct FDA meetings
• Act as liaison and official Correspondent for FDA matters (US Agent)
• Coordinate with FDA staff to implement new regulatory procedures
• Review and comment on submissions/dossiers
• Mentor innovators, entrepreneurs, and founders in the regulatory process
Product Development Services
• Plan and execute product advancement through strategically optimal regulatory process
• Integrate regulatory strategy with research and development programs
• Coordinate pharmaceutical product development
• Develop and manage preclinical drug development programs
• Research and write white papers and position papers
• Submissions planning, development oversight, and review
• Briefing Documents
• Orphan Product Designation Requests
• Electronic submissions
• INDs, Amendments, Annual Reports
• FDA Response Letters
• DMFs and Registration Dossiers including NDAs, 505(b)(2) applications, BLAs