The Industry's Most Talented Microbiology Experts

We partner with our clients to deliver robust and sustainable solutions to ensure the availability of safe and effective medicines and healthcare products.

Our team of consultants possess decades of hands-on, practical experience in pharmaceutical, medical device, biotech and personal care microbiology, sterile and nonsterile manufacturing, drug development, quality assurance, quality control, regulatory affairs, Good Manufacturing Practices (GMP) and global pharmacopoeia compliance.

Our Principal Microbiology Consultant

Dr. Michael J. Miller is an internationally known subject matter expert in pharmaceutical microbiology and rapid microbiological methods. With more than 30 years experience in the field, he is retained as a microbiology consulting resource by the industry's most successful pharmaceutical, biotech, personal care and cell therapy companies. Dr. Miller's CV is available for your review.

Microbiology Consulting Services

Our network of expert microbiologists have practical experience in a wide range of pharmaceutical microbiology areas including:

• Regulatory, GMP and pharmacopeia compliance
• Microbial contamination control strategies for sterile and non-sterile pharmaceuticals, personal care and advanced therapy medicinal products (ATMP)
• Investigation and remediation of microbial contamination in manufacturing, including Burkholderia cepacia complex (BCC), Cronobacter (Enterobacter) sakazakii and Bacillus cereus contamination
• Sterility assurance, sterilization and aseptic processing
• Design, validation and implementation of rapid microbiology methods
• ATMP, gene and cell therapy rapid sterility testing
• Environmental monitoring and microbial identification
• Pharmaceutical grade water system design, validation, monitoring and control
• Preservative effectiveness testing
• Isolator and RABS cycle development and validation
• Failure investigations and microbial data deviations
• Pharmacopoeia method suitability, validation and testing
• Regulatory submissions, audit response (FDA 483 and warning letter) and consent decree management
• Laboratory design, start-up and qualification
• Compounding pharmacy microbiology

Pharmaceutical Microbiology Expert Witness

Dr. Miller has practical experience as an expert witness in patent litigation and product liability cases. He has successfully defended his clients in the areas of pharmaceutical microbiology, contamination control, GMPs, sterility assurance and sterilization, preservative effectiveness, pharmacopoeia (USP) compliance, manufacturing and contact lens care microbiology.

Dr. Miller has represented branded and generic drug companies, plaintiffs and defendants, and has been retained for consultation, patent review, discovery, expert opinion, deposition and trial testimony. Please Contact Us to discuss Dr. Miller's legal fees and availability.