Service 04 / 07
Quality & Compliance Consulting
Quality and compliance consulting builds and audits the quality systems and GxP controls that keep a development and manufacturing operation inspection-ready. NGT BioPharma Consultants helps companies establish, remediate, and defend quality practices in front of health authorities.
In scope
Quality systems, GxP compliance, and inspection readiness across the product lifecycle.
How NGT engages
- Assess where a program stands against health authority expectations.
- Design a plan that fits the modality, the stage, and the target markets.
- Bring in specialist consultants from the 200-plus network as the work requires.
- Coordinate with adjacent disciplines so nothing falls between practices.
Relevant leadership
Backed by NGT's network of more than 200 consultants across every development discipline.
Reference
Frequently asked 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.
Bring NGT into your program
Tell us where your program stands and which disciplines you need. A member of the team will follow up.