NGT BioPharma Consultants

Drug Development & Commercialization Consulting

Drug development and commercialization consulting for biopharma, biotech, and life sciences

NGT BioPharma Consultants is a drug development and commercialization consulting firm founded in 2018 by Michael K. O'Brien, PhD. We partner with sponsors from early development through commercial supply.

Start a conversationView the seven disciplines

Submission fluency

/IND
/NDA
/BLA
/MAA
/CTA
/505(b)(2)

100+

Clients served

200+

Consultants in the network

2018

Founded by Michael K. O'Brien, PhD

PCOE

Pediatric Center of Excellence

Services · 01 / 07

Seven disciplines, numbered like a dossier

CMC and non-CMC regulatory are separate practices at NGT, color-coded apart so you always know which discipline you are engaging.

Regulatory Strategies & Submissions · Non-CMC

02Regulatory Strategies & Submissions ConsultingNon-CMC regulatory: IND/CTA and NDA/BLA/MAA submissions, expedited programs, agency interaction.→

CMC

03Chemistry, Manufacturing & Controls (CMC) ConsultingDrug substance, drug product, and analytical work from early development through commercial supply.→

Development & Operations disciplines

01Nonclinical Sciences ConsultingToxicology, pharmacology, and safety strategy to support first-in-human and beyond.→04Quality & Compliance ConsultingQuality systems, GxP compliance, and inspection readiness across the product lifecycle.→05Global Supply Chain ConsultingSourcing, logistics, and supply planning for clinical and commercial material.→06Biopharmaceutical Digital Innovation ConsultingDigital, data, and technology practices applied to biopharmaceutical development.→07Business Development & Due Diligence ConsultingTechnical and regulatory diligence supporting licensing, acquisition, and investment decisions.→

Modality coverage

Small moleculesLarge moleculesBiologicsVaccinesMedical devicesPediatric Center of Excellence

Selected work

Case studies

Regulatory Strategy

A 505(b)(2) roadmap for a rare-disease candidate

The sponsor of a rare-disease candidate needed a defensible regulatory route and a clear basis for deciding whether to continue the program.

Outcome: The roadmap enabled data-driven go/no-go decision-making, giving the sponsor a documented basis for its program decision.

BLA Resubmission

A BLA resubmission after a Complete Response Letter

A small biotech developing bentracimab, a novel biologic, received a Complete Response Letter that raised CMC findings against its BLA.

Outcome: The program secured a positive Type A meeting result, moving the biologic back onto a forward path.

Candidate Selection

Revitalizing an early clinical program after a lead-compound setback

A mid-size biotech faced a setback with its lead compound and needed a way to keep its early clinical program moving.

Outcome: The PK data mining and microdosing strategy revitalized the early clinical program.

All case studies →
01

Quality

02

Integrity

03

Transparency

04

Honesty

Cover of the white paper: Contractors vs FTEs in Biopharmaceutical Drug Development

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.

Read about the paper

Bring NGT into your program

Tell us where your program stands and which disciplines you need. A member of the team will follow up.

Contact the team