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QUALITY&GMP DEVELOPMENT&OPERATIONS DUE DILIGENCE MANUFACTURING OUTSOURCING CASE STUDIES


Our Team

The major strength of the SpyGlass Group is its interdisciplinary team. Each member brings a particular expertise in an industry, technology or a functional discipline. For each assignment, the client will benefit from the high degree of experience of the SpyGlass Core Team, comprised of professionals with quality assurance, technical operations, project management and business development expertise. Depending on the nature of the assignment, the core team may be augmented by using skilled professionals from the extended team with expertise in clinical development, microbiology, toxicology, regulatory and environmental affairs, etc. Finally, all assessments of technical operations are vetted through a review by the technical advisory board, before the final report is issued to the client. A summary of our team's experiences are shown below, and more detailed biographies are given below (hyperlink)."


Mark Kenny
Managing Director
of the
SpyGlass Group


Lorraine Wearley, Ph.D.
President
Due Diligence
Solutions

Salvatore J. Romano, Ph.D.
Research, Development,
Quality, Regulatory

Denise DeLongis
CEO

Peggy Chong
Operations,
Contract Manufacturing

Judith A. Cherry
Quality Assurance,
GMP Systems &
Project Management

Mike Chang, Ph.D.
Analytical Development,
Technical Services

Robert C. McNeany
Operations

Suzanne Romano, Ph.D.
Business/Corporate Development

Robert J. Serra
Process Development/Validation

Paul Mason, PhD.
Pharmaceutical Sciences
and Development

Robert I. Outwater
Regulatory Affairs &
Health Care Compliance

Luana R. C. Pesco Koplowitz
MD, PhD, FCP, FFPM
President & Chief Medical
and Scientific Officer
of DUCK FLATS Pharma, LLC
Phillip Ross, Ph.D.
Medical Statistics
Kirk Mousley, Ph.D.
Clinical Trial
Data Processing
Ruta M. Slepetys
Clinical Monitoring
and Project Management