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

Jeff Wease

James C. Taylor

Laurie Iciek

Tuan Dinh

Tamara Dubois

Samira Shirwa

Kenneth Guito

Sherri Pike

Sharon Darby

Michael J. Grace

David J. Pepperl

The Business Operations team at Biologics Consulting manages the company's financial health, contract negotiations, and overall business strategy. This includes overseeing accounting practices, enabling efficient contract execution, driving business development initiatives, and ensuring timely and accurate financial operations. The team plays a critical role in supporting the seamless delivery of consulting and support services to our diverse range of clients.

Business Operations

Consulting Team

Regulatory Operations and Publishing Team

Business and Operations

Business Operations

About

Team members

Other teams at Biologics Consulting

Consulting Team

Regulatory Operations and Publishing Team

Business and Operations