About EMN Pharma Consulting
Leading Pharmaceutical Analysis Expertise
EMN Pharma Consulting provides specialized pharmaceutical consulting services with deep expertise in visual inspection methodologies, particulate matter analysis, and ophthalmic product development.
Our principal consultant, Mary Lee Ciolkowski, combines decades of industry experience with cutting-edge analytical techniques to help pharmaceutical companies navigate complex regulatory requirements and optimize product quality.
We specialize in solving challenging analytical problems using forensic microscopy approaches and advanced characterization techniques.
Advanced Analytical Solutions
Microscopy • Spectroscopy • Regulatory Compliance
Our Services
Visual Inspection Consulting
Expert guidance on USP <790> compliance, opaque container testing strategies, and visual inspection program development for pharmaceutical products.
Particulate Matter Analysis
Comprehensive particle characterization using forensic microscopy, spectroscopic analysis, and advanced identification techniques for contamination investigations. Failure investigations and root cause analysis.
Ophthalmic Product Development
Specialized consulting for sterile ophthalmic solutions, including formulation stability, container-closure system evaluation, and regulatory strategy.
Regulatory Compliance
Support for FDA submissions, USP chapter compliance, and international regulatory requirements for pharmaceutical products.
Problem-Solving Investigations
Ultra-microanalysis and forensic approaches to identify unknown contaminants and solve complex pharmaceutical manufacturing challenges.
Training & Education
Customized training programs on visual inspection techniques, particle analysis methods, and regulatory compliance best practices.
Published Research & Portfolio
Access our comprehensive collection of published research, technical documents, and industry presentations.
Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers
Working towards alignment with USP<790> Visible Particulates in Injections. Published in PDA Journal of Pharmaceutical Science and Technology, Vol. 79, No. 1 (January-February 2025).
Download PDF 📄Forensic Microscopy Approach to Identifying Subvisible Particulates
A comprehensive study demonstrating the application of forensic microscopy techniques for identifying and characterizing subvisible particulates in sterile ophthalmic solutions, including progressive analytical approaches and case studies.
Read Full Article 🔗Advanced Analytical Characterization Methods
Research publication detailing innovative analytical methods and characterization techniques for pharmaceutical applications, contributing to the advancement of quality control methodologies in the industry.
Read Full Article 🔗Problem Solving During Trace Foreign Matter Investigations: Points to Consider
Essential considerations for conducting effective forensic microscopy investigations of pharmaceutical contaminants and foreign matter.
Download PDF 📄Visual Inspection Approaches for Ophthalmic Solutions Packaged in Opaque and Semi-Transparent Containers
Presentation from the 2023 PDA Visual Inspection Forum (April 17-18, Baltimore, MD) covering alternative visual inspection test strategies for difficult-to-inspect ophthalmic products.
Download PDF 📄Utilization of a Forensic Microscopy Approach to the Identification of Subvisible Particles in Sterile Ophthalmic Solutions
Presentation from the 2019 PDA Visual Inspection Forum (April 23-24, Washington, DC) demonstrating progressive particle characterization using forensic microscopy techniques.
Download PDF 📄