Today we’d like to introduce you to Brett Vengroff.
Brett, let’s start with your story. We’d love to hear how you got started and how the journey has been so far.
It was late 2008 when the start-up biotech I worked for was acquired and began shutting down operations. I received my notice but was asked to stay on in a consulting capacity to help get everything in order. It was then that I lost my job but gained my first client.
My partner and I founded ComplianceLogix in 2009 to provide regulatory compliance training and consulting services to help organizations build effective quality systems and maintain compliance with FDA and international regulations and guidelines. Since then the organization has grown to include a global network of industry experienced consultants that have supported compliance activities in eighteen countries and our clients now include leading biopharmaceutical companies, international non-profit and contract research organizations.
Has it been a smooth road?
ComplianceLogix has been very fortunate to have had a consistent stream of new clients and referrals by maintaining a reputation for providing effective compliance services.
Cambridge has such an amazing network of biotechnology, pharmaceutical and medical device professionals it would be difficult not to bump into an old friend or colleague just walking around. When I can, I enjoy working at a local coffee shop surrounded by the excitement of all the entrepreneurs, students and innovators around me at each table.
So let’s switch gears a bit and go into the ComplianceLogix story. Tell us more about the business.
Our services include Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) training, clinical audits, vendor audits, batch record review, Standard Operating Procedure (SOP) writing, and quality systems implementation. Our consultants work according to the same procedures, which allows us to provide standardized reporting and meaningful metrics to support a client’s quality program.
ComplianceLogix’s online training platform provides an efficient, cost-effective means to provide compliance training specific to client needs which allows each individual to train independently, in the office or remotely, on their own schedule.
But what sets ComplianceLogix apart may also be what we do not do. A few years ago a mid-sized pharmaceutical company requested a detailed gap assessment of their system of over 1,500 procedural documents. The project would have taken several consultants a few months to complete, with numerous committees and steering committees meeting regularly to monitor progress. After the initial assessment they would determine what was already known – there were too many procedural documents! We proposed to save months of analysis and move directly to integrating these documents in an organized manner by function into a more efficient quality system with an overall reduction of 90% of the current number of procedural documents.
How do you think the industry will change over the next decade?
There have been a number of large acquisitions both by Sponsor and contract service providers. These changes may provide potential pitfalls for the overall quality of the organization if sites are not integrated appropriately. At best, there is the potential for the sharing of best practices which may improve overall compliance.
I really enjoy meeting and working together with teams of people dedicated to improving the lives and outcomes of their patients.
- Address: ComplianceLogix
955 Massachusetts Ave. #430
Cambridge, MA 02139
- Website: www.ComplianceLogix.com
- Phone: 617.575.9259
- Email: firstname.lastname@example.org
- Facebook: https://www.facebook.com/ComplianceLogix/
- Twitter: https://twitter.com/compliancelogix
- Other: https://www.linkedin.com/company/compliancelogix