Principles to Practice - Operations and Compliance
R&D, GLP, GMP - are you (or your contract organization) using the appropriate quality system to minimize the risk to your critical materials and data? Let us help you verify the applicable requirements and confirm that they are being followed at the bench.
Inspection coming? Don't let the inspector be the first one to point out method problems or laboratory compliance gaps. We have decades of personal experience in both receiving and conducting pre-approval inspections (PAI) and routine GLP and GMP inspections.
Known problems? We have participated in dozens of analytical troubleshooting and compliance observation remediation plans to help firms achieve successful outcomes.
We have seen hundreds of good operational examples, and thousands of good examples of bad operational examples!
"Smooth Seas Do Not Make Skillful Sailors"
Over the years, we have helped guide many clients through the roughest project "hurricanes" and operational "tornadoes" of both large and small firms.
By continuous participation in numerous scientific conferences, forums and publications, we are very engaged in the field of biopharmaceutical product CMC issues. Our extensive pro bono scientific activities assure that we remain current on industry best practices and regulatory expectations.
From these activities as well as from client projects that span the industry around the world, we can rapidly detect emerging trends. With a wide range of hands-on experiences, we have real-world knowledge of what works (and what doesn't).
All of these features combine to provide highly effective input to our consulting and training services. Utilize our skills to help navigate your course, too!