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Meet SopReg Consulting: Experts in Regulatory Excellence
Our Team
At SopReg Consulting, our team comprises seasoned professionals with extensive expertise in regulatory operations, document management, global submissions, and project management. Together, we bring a wealth of experience and a commitment to ensuring our clients' success in navigating complex regulatory landscapes.
They excel in managing end-to-end regulatory submission processes, including eCTD publishing, validation, and ensuring compliance with global standards. The team has extensive expertise in preparing and managing submission-ready documents throughout their lifecycle while navigating complex regulatory requirements for agencies like the FDA, EMA, and MHRA. With experience in submissions such as INDs, NDAs, BLAs, and MAAs, they collaborate closely with cross-functional team members—including regulatory affairs, clinical operations, quality assurance, and manufacturing teams—to ensure seamless communication, efficient project execution, and alignment with international guidelines, minimizing risks and delays.
Regulatory Operations Specialists
Our regulatory operations experts are adept at managing end-to-end submission processes. From eCTD publishing and validation to addressing health authority requirements, they ensure all submissions meet global standards, minimizing risks and maximizing efficiency.
Document Management Professionals
Our team excels in document preparation, organization, and lifecycle management. With a meticulous approach to formatting and compliance, we ensure all documents are submission-ready and aligned with regional and global guidelines.
Global Submissions Experts
With extensive experience in regulatory submissions to agencies like the FDA, EMA, and MHRA, our global submissions team ensures timely and accurate filings. Their expertise spans various submission types, including INDs, NDAs, BLAs, and MAAs, ensuring alignment with international regulations and expectations.
