A consulting firm built the way a dossier is built
NGT BioPharma Consultants is a drug development and commercialization consulting firm founded in 2018 by Michael K. O'Brien, PhD. It serves biopharmaceutical, biotech, and life sciences companies across small molecules, large molecules, biologics, vaccines, and medical devices.
The firm was founded in 2018 by Michael K. O'Brien, PhD, who serves as President and CEO. From the start it has worked as a partner to sponsors rather than a vendor at arm's length, joining programs from early development through commercial supply.
More than 100 client companies have engaged NGT, drawing on a network of more than 200 consultants across every development discipline. The firm works with small and large molecules, biologics, vaccines, and medical devices, and maintains a Pediatric Center of Excellence.
At a glance
- 100+
- Clients served
- 200+
- Consultants in the network
- 2018
- Founded by Michael K. O'Brien, PhD
- PCOE
- Pediatric Center of Excellence
Core values
Quality
The standard every submission, plan, and report is held to before it leaves the firm.
Integrity
Straight assessments, including the ones a sponsor may not want to hear.
Transparency
Clear reasoning and clear pricing, so a client always knows where a program stands.
Honesty
No overstated claims. The absence of hype is the point.
Focus area
Pediatric Center of Excellence
NGT maintains a Pediatric Center of Excellence, a dedicated focus for the regulatory and development questions that pediatric programs raise, including rare pediatric disease work handled through the regulatory strategy practice.
Modality coverage
White paper · August 2025
Contractors vs FTEs in Biopharmaceutical Drug Development
A white paper on when contractors and full-time employees each make sense in a biopharmaceutical development organization, drawn from NGT's work across more than 100 client companies.
Request the paperReference
About NGT: common questions
What does NGT BioPharma Consultants do?
NGT BioPharma Consultants is a drug development and commercialization consulting firm founded in 2018. It supports biopharmaceutical, biotech, and life sciences companies across nonclinical sciences, regulatory strategy, CMC, quality and compliance, supply chain, digital innovation, and business development.
Who founded NGT BioPharma Consultants?
The firm was founded in 2018 by Michael K. O'Brien, PhD, who serves as President and CEO.
What modalities does NGT work with?
NGT works across small molecules, large molecules, biologics, vaccines, and medical devices, and maintains a Pediatric Center of Excellence.
How large is NGT's consultant network?
NGT has served more than 100 clients and works with a network of more than 200 consultants across every development discipline.
Bring NGT into your program
Tell us where your program stands and which disciplines you need. A member of the team will follow up.