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Trusted Adjuncts

When clients need other help with their business, these are some of the industry experts we suggest they consider.

We know each one of the below firms personally, so if you have specific questions or need more information before you contact them, email us and we’ll try to answer or help in any way.

Dangerous Document Workshops

Nancy Singer turns her experience as a former FDA and Department of Justice prosecutor to teaching executives the risks and pitfalls of sloppy emails, communications, and documents.  Her Dangerous Documents workshop has been written up in the Wall Street Journal, the Washington Post, and numerous other media outlets.

Operational Excellence for Medical Device Firms

Focusing on operations management with small medical device manufacturers, Dan O’Leary brings 26 years of career experience to help companies effectively solve and eliminate operational and regulatory problems, from techniques to improve manufacturing processes and forecast models, to implementing OSHA standards and achieving ISO or Six Sigma.

Web Development

Designers of this website and hundreds more, Jigowatt Ltd has built an international reputation for award-winning designs, customer service and technical excellence.  Take a look at their own site and you’ll see why.

FDA SAS Validation and Auditing

Joshua Sharlin, Ph.D. is a former FDA reviewer and instructor for SAS Institute. He has substantial hands-on software development and IT experience. His 20 years of industry consulting experience includes GCP and Part 11 auditing of sponsors, CROs, vendors, clinical sites and software developers, SOP writing, data integrity evaluation, regulatory affairs, and preparation of drug and device submissions. Contact Dr. Sharlin through his firm, Sharlin Learning & Consulting.

Market & Competitive Intelligence Research

An international collection of experts, the Global Consulting Network provides independent expertise in every region of the globe.  Members must meet consensus standards on work quality, expertise level, and capabilities; each member firm has a distinct specialty (for instance, Cerulean provides competitive intelligence on FDA, ICH, and IMDRF activities).