PharmaLex US Corporation

PharmaLex is one of the largest providers of development consulting, regulatory affairs, quality management and compliance, and pharmacovigilance worldwide. Its teams of experts guide clients from early strategic planning, CMC and non-clinical requirements through clinical development, regulatory submission processes, and finally to market approval and post-launch product maintenance, with regulatory experts ready to assist with CMC and pharmaceutical quality, planning, authoring, reviewing, revising and submitting CMC documentation in collaboration with clients' production, quality control, regulatory affairs and pharmaceutical development specialists for any health agency worldwide, addressing today's ever-changing regulatory environment with expertise and innovative solutions.