Other Specialties 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
• International Project Management
  
• ​Clinical Trial Material Manufacturing and Packaging Management

CMC Regulatory

​Responsible for the CMC sections of multiple NDAs that were all approved within the established PDUFA time frame.

Assisting the biopharmaceutical industry with their CMC regulatory, analytical chemistry, and product development outsourcing needs.

Lone Pine CMC Consulting, Inc.​

​CMO/CLO Oversight

Broad experience base in selection, auditing, and oversight of international and domestic contract laboratories and contract manufacturing facilities.

Product Development

Supporting development of pharmaceutical products from Phase 1 through commercialization.