News & Insights
“What is Ex Vivo Gene Therapy, and What Regulatory Challenges do Developers Face?” Featuring Robert Kutner
Using your own cells to help you heal isn't science fiction anymore. Today, we’re diving deep into the exciting world of ex vivo cell therapy with Robert Kutner of Biologics Consulting, exploring exactly what ex vivo cell therapy is, how it helps fight rare diseases and cancer, and the regulatory disadvantages that producers face.
Connected Medical Devices and Public Cloud Services
Public cloud computing services are being increasingly used by medical device manufacturers to house components of medical device software. In this post, I am referring to a public cloud as defined by NIST SP 800-145:2011, The NIST Definition of Cloud Computing, and their “platform-as-a-service (PaaS)”…
Deltek MVP Award – Professional Services Category!
Way to go Team! We are thrilled to announce that Biologics Consulting is a 2022 Deltek MVP Award winner in the Professional Services Category! We accepted our award at #DeltekProjectCon in front of 3,000+ customers for our upgrade to Deltek Vantagepoint to further modernize our software tools…
“How a Consultant can Support Your Regulatory Compliance with a Gap Analysis” Featuring Dr. Debra Barngrover
Bringing a drug or device to market can be arduous. There are so many difficulties that can arise, from ensuring safety and efficacy with GMP, to navigating regulatory compliance. In this interview with Debra Barngrover of Biologics Consulting, we learn how a consultant can help bring your picture into focus through a gap analysis and other strategic approaches.
CMC Business Unit Meeting
In late September, the Biologics Consulting CMC Business Unit met at the Alexandria Headquarters for an all-day team meeting. The meeting created some insightful discussion that focused on the overall CMC strategic plan and growth initiatives as well as broader company updates. After a productive meeting…
Biologics Consulting attends RAPS Convergence
Some of our Biologics team had a good experience attending this year's RAPS Convergence conferences in Phoenix, Arizona. They met with some current clients and made some introductions with some companies in need of regulatory support. The team enjoyed the opportunity to be back in person to share…
Nonclinical Business Unit Meeting
The Biologics Consulting Nonclinical Business Unit had a productive team meeting on August 3rd and 4th at the Alexandria Headquarters. After some general company discussions and updates, the team launched into strategic planning sessions for the upcoming year and Dr. Emily Noonan-Place provided some…
CMC Business Unit Welcomes Vidhya Mathiyazhagan
Biologics Consulting is pleased to welcome Vidhya Mathiyazhagan to the CMC Business Unit. Vidhya comes to us from Bluebird Bio with more than 10 years of experience in biologics QC and analytical development. Vidhya is a CMC Technical Writer with past experience in authoring submissions for FDA, EMA…
Regulatory Project Management Business Unit Meeting
The Biologics Consulting Regulatory Project Management Business Unit had a productive team meeting on July 14th at the Alexandria Headquarters office. They were able to nurture their collaboration as a business unit, focus on areas of team and personal improvement, create deliberate dialogue related…
Biologics Consulting welcomes Rita Wilson, MS to project management team
Biologics Consulting is pleased to welcome our newest Regulatory Project Manager (RPM), Rita Wilson, MS to our project management team. She joins us from sunny San Diego, CA with 14 years of clinical and global regulatory experience in various therapeutic areas. Recently, she was a Senior Manager at…