Emil W. Ciurczak
Doramaxx Consulting Near-Infrared/Raman/PAT/QbD/DoE
INDATECH (part of Chaivin Arnoux family) 4 rue Georges Besse, 34 830 Clapiers, Fran firstname.lastname@example.org
INDATECH provides hardware and software for monitoring and controlling pharmaceutical process at full speed. The technology is based on NIR or Raman Hyperspectral camera is used to image a sample through optical fibers. The specra generated by these devices may be used for simple measurements, such as moisture, through more complex measurements, such as assays, uniformity, capsule fill, hardness of tablets. Samples
may be tablets, capsules, or vials, both as they are manufactured or later, in blister packs
4Tune Engineering Av. Antonio A. Aguiar 108, 5, 1050-019 Lisbon, Portugal www.4TuneEngineering.com
With the increased demands for risk-based decisions, companies need corporate solutions supporting Quality Risk Management approaches throughout the life cycle of their products. iRISK enables just that by applying the best principles and tools to ensure that your risk activities are aligned with FDA, GMP-Annex 15, EMA, and ICH guide- lines. iRISK is a a risk-management platform to identify, quantify & prioritize risks, supporting risk-mitigation strategies for new or existing processes. iRISK is an integrated platform for risk-management over lifecycle and tailored to you User Requirements Specifications.
phone +351 21 606 2788 (general)
phone +351 21 315 0147 (conference room)
fax +351 21 606 2790
Some Worthwhile Consultants
Compliance and Lab Safety:
With 40 years of experience in cGMP analyses and compliance, Gary has both worked in industry, been part of consent decree activities, has worked t the USP, and has patents in medical and pharmaceutical devices He also presents Short Courses on Lab Safety and Validation and Calibration of Spectrophotometers.
Spectroscopic Instrumentation Design and Construction:
John Coates, Ph.D. Coates Consulting, LLC http://www.coates-consulting.com/
With many years of custom design and building spectrometers for specific uses. Numerous compact spectroscopic instruments now on the market have been designed by John. Prototypes through product completion. John performs his consulting and prototyping in a modern 2000 sq ft laboratory in Connecticut. The lab includes a wide range of spectroscopic instruments for reference and for his spectroscopic consulting services…plus uses instruments to model applications and to prototype instrumentation concepts. His major design focus includes portable and handheld instruments.
Specialty Chemometric/Statistical Software, Statistical Design, Chemometrics:
Howard Mark, Ph.D. Near Infrared Research Corporation http://www.nearinfrared.com/
Over 40 years of experience in Chemometrics, statistics, software writing, and instrument design for NIR, Howard is a world-class consultant, author and lecturer. My co-presenter for the ACS and CfPA NIR Short Courses and coworker for 35 years. Howard was thrown chin-first into NIR shortly after Karl Norris invented the technology. Of necessity, he therefore had to develop most of the techniques we use today, to collect the data and perform the mathematical analysis that gives NIR its power, including some that never made it into the open literature. [He taught me almost everything I know about calibrating instruments.]