Services Offered

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With over 40 years of experience in technical systems, compliance, process optimization, and improvement—including more than 30 years in operations requiring FDA and EU regulatory compliance—this consultancy brings extensive knowledge of facilities, utilities, equipment (including Blow/Fill/Seal and patch coating systems), and instrumentation used to support GMP production.

 

Experience includes participation in four facility build-out and expansion projects, encompassing commissioning of facilities, utilities, and production equipment. Prior service in the U.S. Naval Submarine Force as a Navigation Electronics Technician provided significant technical and supervisory experience, instilling a discipline and work ethic that continues to guide professional practice.

 

Hard work, integrity, and high ethical standards are considered essential to individual and organizational success. Teams in quality engineering, validation, metrology, project management, and technical services have been successfully managed, bringing relevant expertise to achieve outstanding results across diverse projects.

 

A results-driven, “right-first-time” approach ensures that skills and experience consistently exceed expectations when applied to new challenges.

 

Lead or support services are provided in the following areas:

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• Process Validation – BFS, OTC, Patch Coating, Aseptic Liquid Filling

• Process Simulation (Media Fill)

• Product and Process Transfer / Scale-Up

• Process Optimization

• Commissioning and Qualification – Equipment, Utilities, and Facilities

• Cleaning Validation – CIP, COP

• Steam-in-Place (SIP)

• Failure Investigation and Root Cause Analysis

• Project Management

• Laboratory Instrument Validation

• Staff Augmentation

 

On-site and remote services support pharmaceutical and biotech production equipment projects, leveraging decades of experience. Specialization includes consulting for the installation or upgrade of BFS production lines, guiding clients from design and equipment selection through process validation.

 

Services aim to minimize project delays and encompass site acceptance testing (SAT), installation optimization, BFS process development, commissioning and qualification, process simulation (media fill), and process validation. Current knowledge of FDA, EU, and animal health regulations is maintained. Fully insured up to $1 million.

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