ABOUT
Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the nearly three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market in the US.  Our team of consultants and professional services staff is comprised of subject-matter experts with decades of industry and/or FDA experience that allows us to provide an unparalleled insider perspective.

OUR DIFFERENCE
The Biologics Consulting difference is all about the unique combination of expertise we have under one roof.  Our team has depth of knowledge and breadth of experience across all product types and development pathways. This value proposition allows us to address the full scope of a client’s regulatory and product development challenges.

OUR EXPERIENCE AREAS
-	Biologics
-	Medical Devices
-	Pharmaceuticals
-	Biosimilars

OUR SERVICES
-	CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support. 
-	SUPPORT SERVICES – Medical Writing, ePublishing & Submissions, US Agent Services, Due Diligence
	
OUR CLIENTS
Our clients span the industry, from established multi-national pharmaceutical, biotechnology, and medical device companies to academic and research institutions. We also support small biotech and medical device start-ups. Since our founding, we have professionally services over 4,500 clients from 58 different countries.

Biotechnology

Medical Devices

Biologics Consulting

Margaret Vernon

Kenneth Guito

Sherri Pike

Sharon Darby

Michael J. Grace

Mckenzie Orchowski

David J. Pepperl

The Consulting Team at Biologics Consulting provides expert guidance in regulatory affairs, product development, clinical planning, and quality support for biologics, pharmaceuticals, medical devices, and gene and cell therapy products. Comprised of highly experienced senior consultants, the team leverages their extensive industry and FDA backgrounds to help clients navigate the complexities of bringing innovative products to market.

Consulting Team

Regulatory Operations and Publishing Team

Business and Operations

Consulting Team

About

Team members

Other teams at Biologics Consulting

Regulatory Operations and Publishing Team

Business and Operations