Technical Operations, Clinical and non-clinical study oversight, regulatory affairs, and compliance
GxP Compliance, Custom Built for Emerging Biotech
We help biotech and clinical-stage companies build the infrastructure, quality systems, documentation, and regulatory strategies they need to move from discovery to the clinic — with confidence.
20+
Years of Industry Experience
150+
Engagements Completed
12
Regulatory Frameworks Covered
100%
Client Audit Success Rate
What We Do
Comprehensive QA & Technical Operations Services
GxP Compliance
End-to-end GMP, GLP, and GCP compliance programs tailored to your stage of development. We assess gaps, build frameworks, and prepare your organization for regulatory scrutiny.
Quality Systems
Design and implementation of scalable Quality Management Systems (QMS) — from document control and CAPA to deviation management and change control.
SOP Development
Authoring and review of Standard Operating Procedures that meet FDA, EMA, and ICH requirements. Clear, audit-ready documentation your team will actually use.
Regulatory Submissions
Technical writing and CMC support for IND, NDA, BLA, and MAA submissions. We translate your science into regulatory-ready documentation.
Process Validation
Validation strategy, protocol authoring, and execution support for manufacturing processes, cleaning, and analytical methods — aligned with current regulatory expectations.
Audit Readiness
Pre-inspection assessments, mock audits, and remediation support to ensure your organization is prepared for FDA, EMA, or notified body inspections.
Why GXP Consulting
We've guided dozens of biotech companies through their first GxP milestones.
We understand the unique pressures of early-stage biotech — limited resources, aggressive timelines, and zero margin for regulatory missteps. Our team brings the experience of large pharma with the agility your organization needs.
- Deep expertise across small molecule, biologics, and cell & gene therapy
- Practical, right-sized solutions — not one-size-fits-all enterprise frameworks
- Former FDA reviewers and industry veterans on our team
- Embedded partnership model — we work alongside your team, not above it
Ready to build a quality foundation that scales?
Whether you're preparing for your first IND or scaling toward commercial manufacturing, we'll meet you where you are.
No retainer required. Start with a discovery call.
Request a Consultation