Our team is comprised of well established scientists within the pharmaceutical industry who have either led or were part of teams that have successfully dealt with the most complex investigations under regulatory scrutiny, using advanced statistical analysis methods.
Our team has led complex investigations under regulator scrutiny, time and resource constraints and prevailed to get products back on track.
No one investigation fits all and our methodology is like no other, developed over years of knowledge and acquired experience.
With multiple organizations, sites, clients and different type of products, our team combined has seen hundreds of molecules and formulation so surprising our team will be a challenging task.
Our team can address any urgent calls to support immediate troubleshooting on the production floor.
We all know and understand that time is money and patients need their products, so any delay has to be dealt with immediately. That's why we are here.
Preventative programs have been in use for many years and have proven efficient over the years.
Our team is well versed with the methodologies and combined with the extensive knowledge and experience acquired over the years with dozens of molecules and formulations successfully examined, will be able to support any Risk Assessment Program and FMEAs.
Our team has a dedicated member to training plans establishment.
Depending on your needs, our team will support establishment of new programs inclusive of all documentation involved, as well as hands on training on variety of equipment trains.
Since the inception of FDA PPQ Guideline back in 2011, many programs have been developed by companies and organizations in an attempt to stay current and compliant.
Our team studied multiple programs and have dealt with many challenges experienced by numerous organizations which provided great experience and knowledge that will benefit your organization.
We are well versed in statistical analysis methodologies and able to support registration, investigations, stability trends, recalls and more.
Automated documentation system is essential to your organization success.
Keeping the proper flow with an automated text, will decrease both cycle time and documentation error dramatically.
We have implemented systems and processes that will support your organization and bring it up to the next level.