CMC Consulting

Pharmaceutical Solutions

As an independent scientist working closely with her clients, Dr. Judy Senior provides consultation and scientific support in the areas of product development, especially sterile product GMP manufacturing, CMC regulatory isues, formulation development, and drug delivery systems. Dr. Senior assists with technical report writing and review, study management, quality assurance, quality system design and implementation, and regulatory document preparation including INDs and NDAs.

Examples of past CMC projects:

CMC Support - Phase I study material manufacturing and IND preparation (Houston-based start-up company). Phase II clinical drug supply management (San Diego-based company). Sterile manufacturing.

Analytical Method Development - Audits of specialty laboratories, method validation support, compliance, PAI preparations (S. California Pharma Company)

Pharm/Tox Support - IND preparations and study site audits (multiple companies)

Quality Assurance - Quality documentation including GAP analyses, Quality Manual, SOPs Quality System design and implementation, etc.

Project Management - CRO interactions, virtual companies, teamwork, problem solving, program management