Lone Pine CMC Consulting, Inc.

Pharmaceuticals - Terrebonne, Oregon, United States

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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 commercializationIf you have a development challenge, or just need additional support with your current workload, contact Lone Pine CMC Consulting today!

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Employees: 1
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Location: Terrebonne, Oregon, United States
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