Categories
Lumanity – Clinical & Regulatory
About CRO
About Organization
Lumanity’s Clinical & Regulatory team helps life science companies unlock breakthrough value by transforming their clinical and regulatory strategy. They help advance therapies from early development through approval with strategic, scientific, and regulatory expertise. Their multidisciplinary teams integrate clinical, CMC, nonclinical, regulatory, and quality insights to de-risk programs, accelerate timelines, and optimize outcomes. Acting as an extension of your development team, Lumanity supports regulatory submissions, agency interactions, quality systems, scientific stewardship, and clinical trial optimization.
Why Choose Lumanity?
Cross-Functional Expertise: Integrated teams across regulatory, clinical, CMC, and nonclinical disciplines.
Regulatory Intelligence: Deep knowledge of FDA, EMA, MHRA, PMDA, and global pathways.
Operational Acceleration: Optimized protocols, site activation, patient recruitment, and trial delivery.
End-to-End Support: From early strategy through submission, advisory meetings, and post-approval guidance.
U.S. Headquarters: 10 North Park Place, Suite 201, Morristown, New Jersey, 07960
Core Services
Lumanity provides end-to-end support across the drug development lifecycle, including strategic planning, regulatory strategy and filings, quality and compliance oversight, scientific guidance, and clinical trial optimization. They prepare and submit global regulatory filings, conduct GxP audits, strengthen Quality Management Systems, and guide sponsors through agency and advisory meetings. Their team also translates scientific data into regulatory-compliant claims, provides expert testimony when needed, and optimizes clinical protocols, site activation, and patient recruitment. By combining operational and regulatory expertise, Lumanity helps sponsors accelerate development while minimizing risk.
Accreditations & Compliance
Lumanity offers GxP quality and compliance support, including FDA audit readiness and GxP gap analyses, and supports global regulatory strategy aligned with major health authorities such as FDA and EMA.
What development stages does Lumanity support?
From preclinical planning through pivotal trials, regulatory submissions, advisory meetings, and post-approval needs.
Do they support FDA and EMA engagements?
Yes — including Type B/C meetings, Scientific Advice, and CHMP preparation.
Can Lumanity help repair a struggling clinical program?
Absolutely — they specialize in trial acceleration, remediation, and vendor/site alignment.
Do they prepare full regulatory submissions (IND/NDA/BLA/MAA)?
Yes — including authoring, publishing, and cross-functional coordination.
Does Lumanity provide QMS and GxP audit support for early-stage biotech?
Yes, including full QMS builds, SOPs, gap analyses, and vendor qualification audits.
