FDA Regulatory Consulting & Product Development Consulting Biologics, pharmaceuticals, medical devices & more.
Give you an edge
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Regulatory and Former FDA expertsOur Expertise
By partnering with us, you gain a strategic advantage in a rapidly evolving biotech landscape. We stay at the forefront of global regulatory updates, industry trends, and technological advancements, ensuring that you benefit from the latest insights and best practices. Our commitment to excellence, unwavering client focus, and dedication to advancing patient care make us your trusted partner in transforming the life sciences industry.
Our Difference
The Biologics Consulting difference is the world-class combination of expertise we have under one roof.
World-renowned scientists and physicians
Full scope of FDA regulatory support needs
Turning raw data into stories that resonate
Building global partnerships for regulatory success
Our Services
Our proven success will give you an edge while navigating the complex and nuanced regulatory pathway.
Our Team
Our consultants are here to help you navigate the regulatory process and provide you with the best strategy for success.
News and Insights
Biologics Consulting Appoints Dr. Margaret K. Vernon As Its New Chief Executive Officer
Biologics Consulting Group, Inc. is pleased to announce the appointment of Dr. Margaret K. Vernon as Chief Executive Officer, effective September 18, 2023.
SOLVING CHALLENGES FOR ADVANCED CGT DEVELOPMENT
Over the past several years, novel cell and gene therapy (CGT) products have rapidly progressed through the clinic, and several have gained regulatory approval. Advances in both cell and molecular biology as well as immunology and more efficient manufacturing paradigms have led to an explosion in new CGT products.
Gone are the days of relatively straightforward plasmid DNA and stem cell therapies. Today, new product paradigms including CAR-Ts, novel viral vectors, microbiome-derived bacterial products, phage therapies and mRNA therapies constantly provide new challenges to product developers.
What are some of the scientific, quality, and regulatory hurdles developers face with novel CGT products and how can biotech work most effectively with regulators to get these promising products into patients? Our panel will discuss some of the CMC and nonclinical challenges commonly faced with novel CGT products and how we might overcome them to bring these complex, but promising therapies to the clinic.
Listen in to Mike Grace, David Pepperl, Diana Colleluori, Robert Kutner, and Chris Scull as they discuss the challenges and some solutions.