News & Insights
Biologics Consulting Adds CMC Expert Robert Kutner To Growing Team
We welcome Robert Kutner as a new addition to the CMC Business Unit at Biologics Consulting this week! Robert is a technical and regulatory expert in cell and gene therapy process and analytical development. Robert comes to us from Avrobio, Inc., where he was Head of Process and Analytical Development…
Biologics Consulting Welcomes Jenny Xiradakis, B.Sc. Pharm to its CMC Business Unit
Biologics Consulting is pleased to welcome a new member to our CMC Business Unit - Quality and Compliance Group, Ms. Jenny Xiradakis, B.Sc. Pharm. Jenny joins Biologics after 16 years at FDA (CDER), Office of Pharmaceutical Quality/Office of Surveillance, and the Office of Regulatory Affairs, New York…
Biologics Consulting Expands With Addition of Dr. Emily Noonan-Place, PhD, MPH
Biologics Consulting is pleased to welcome a new member to its Nonclinical Team, Dr. Emily Noonan-Place, Ph.D., MPH. Emily joins Biologics Consulting after 9 years at FDA (CDER), Office of Oncologic Diseases and has extensive experience with small molecules, biologics (mAbs, ADCs, bi-specifics), oligonucleotide…
The Right CMC Consultant Can Save You Time and Money
You are developing a new pharmaceutical product and think you would benefit from the services of a consultant with expertise in the Chemistry, Manufacturing, and Controls (CMC) requirements of global pharmaceutical regulatory bodies, but you also need to make the most of your CMC budget. Although CMC…
Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on "Vaccine Stability Considerations to Enable Rapid Development and Deployment", on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry,…
Overview of FDA Timelines Associated with Traditional 510(k)s
The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees are intended to be used by FDA on the resources needed to support the review of marking applications…
What is Drug Development Tool Qualification? Is it Part of the Critical Path?
A new guidance from FDA last month may be adding to confusion in industry regarding the difference between FDA requirements and programs that are voluntary. At first glance, the title "Qualification Process for Drug Development Tools" might suggest that the FDA has new expectations for sponsors planning…
Breakthrough Designation: Is it the path for your device?
Overview You are working on creating a novel new device. It is an exciting time! But with novelty comes many unanswered questions, including what is the best regulatory pathway. The Breakthrough Device Program may be a part of that pathway. In this paper, consultants Christy Foreman, MBE and Becky Ditty…
A Valuable Research Tool
The FDA Purple Book Database: A Valuable Research Tool So, what exactly is the FDA Purple Book Database? First a few things it is not:a book purpleThe Purple Book Database is a list (downloadable or searchable on-line at https://purplebooksearch.fda.gov/ ) of all FDA approved biological products…