Our Services
End-to-End GxP Consulting Services
From your 1st IND to commercial readiness, we provide the technical, regulatory and compliance expertise that clinical stage biotech companies need to move forward with confidence.
We work alongside your team — not above it. Every engagement is scoped to your stage, your resources, and your regulatory timeline.
01
GxP Compliance
Build a compliance program that scales with your pipeline.
We assess your current state against FDA, EMA, and ICH GxP requirements and design a compliance roadmap tailored to your development stage. Whether you're establishing your first GMP program or remediating gaps ahead of an inspection, we bring the rigor of large pharma with the agility early-stage companies require.
Capabilities
- GMP, GLP, and GCP gap assessments
- Compliance program design and implementation
- Regulatory intelligence and horizon scanning
- Pre-inspection readiness reviews
02
Quality Management Systems
Scalable QMS architecture built for growth.
A well-designed Quality Management System is the backbone of every successful regulatory submission. We design, implement, and optimize QMS frameworks — from document control and CAPA to deviation management and change control — that meet current regulatory expectations and scale as your organization grows.
Capabilities
- QMS design and implementation
- Document control system setup
- CAPA and deviation management
- Change control program development
- QMS software selection and validation
03
SOP Development
Audit-ready documentation your team will actually use.
Standard Operating Procedures are only valuable if they're accurate, compliant, and followed. Our team authors, reviews, and revises SOPs across all functional areas — manufacturing, quality control, clinical operations, and more — ensuring they meet FDA and ICH requirements while remaining practical for your staff.
Capabilities
- SOP authoring and technical writing
- SOP gap analysis and remediation
- Cross-functional SOP review programs
- Training program development
- Periodic review and lifecycle management
04
Regulatory Submissions
Technical writing and CMC support for global submissions.
We translate your science into regulatory-ready documentation. Our team provides technical writing and CMC support for IND, NDA, BLA, and MAA submissions — helping you present your data clearly, completely, and in the format regulators expect.
Capabilities
- IND, NDA, BLA, and MAA preparation
- CMC section authoring and review
- Module 3 CTD documentation
- Regulatory agency meeting preparation
- Response to information requests
05
Process Validation
Validation strategy aligned with current regulatory expectations.
Process validation is a critical milestone on the path to commercial manufacturing. We develop validation strategies, author protocols, and support execution for manufacturing processes, cleaning validation, and analytical method validation — all aligned with FDA Process Validation Guidance and ICH Q8/Q9/Q10.
Capabilities
- Validation master plan development
- Process, cleaning, and analytical method validation
- Equipment qualification (IQ/OQ/PQ)
- Computer system validation (CSV)
- Continued process verification programs
06
Audit Readiness
Prepare your organization before regulators arrive.
An FDA or EMA inspection is not the time to discover gaps. We conduct pre-inspection assessments and mock audits that mirror real regulatory scrutiny — identifying vulnerabilities, prioritizing remediation, and coaching your team so they're confident and prepared when the day comes.
Capabilities
- Pre-inspection gap assessments
- Mock FDA and EMA audits
- Supplier and vendor qualification audits
- Audit response and CAPA development
- Inspection management and back-room support
Not sure where to start?
Most of our engagements begin with a no-obligation discovery call. We'll assess your current state and recommend the right scope for your stage.
No retainer required. Start with a discovery call.
Schedule a Discovery Call