Lone Pine CMC Consulting, Inc. provides pharmaceutical and biotechnology companies with the support they need to gain FDA approval for their drug products. Areas of expertise include * Preparing CMC Sections of Regulatory Submissions (eCTD, NDA, IND, BLA, etc) * Direct FDA interactions, including: Pre-IND, End-of-Phase 2, Pre-NDA, Type A, B, and C Meetings, and Specification Negotiations * Technical Writing * CMO/CLO oversight * International Project Management * Due Diligence for New Products * Clinical Trial Material Manufacturing and Packaging Management * Product development support of pharmaceutical products from Phase 1 through commercialization If you have a development challenge, or just need additional support with your current workload, contact Lone Pine CMC Consulting today!