Pharmaceutical Quality Assurance Consulting
Build a quality system that works in practice, stands up to inspection, and grows with your company. We help pharmaceutical and biotech teams design, strengthen and run GxP-compliant quality operations — from first SOP to inspection day.
Quality Assurance is where regulatory expectations meet day-to-day operations. A quality management system (QMS) that looks complete on paper but is not followed on the floor is one of the most common causes of inspection findings, warning letters and delayed approvals. Equally, a system that is heavier than your company needs slows every batch, study and release.
Radical Pharma Consultancy helps you find the right balance. Our consultants have spent their careers inside pharmaceutical quality functions, including more than a decade at Mylan in the UK and Canada, so we understand how quality systems are actually used — and how inspectors from the FDA, Health Canada, the MHRA and EU authorities assess them.
Whether you are a start-up writing your first SOPs, a growing company preparing for a pre-approval inspection, or an established manufacturer tightening vendor oversight, we deliver practical, right-sized quality solutions and leave your team able to sustain them.
Quality Assurance Services
QMS Development & Review
We design new quality management systems and review existing ones against current GxP expectations, aligned with ICH Q10 and scaled to your stage.
- Quality manual and QMS architecture
- Document control, change control, deviations and CAPA
- Training, complaints and management review processes
- QMS gap assessment with a prioritised remediation plan
GMP / GCP / GLP Compliance
Hands-on support to meet the requirements that apply to your products, studies and markets.
- GMP: 21 CFR 210/211, Health Canada GMP, EU GMP (EudraLex Vol. 4), ICH Q7
- GCP: ICH E6 oversight of CROs, sites and trial master files
- GLP: 21 CFR Part 58 and OECD GLP principles
- Data integrity and computerised systems (21 CFR Part 11, EU Annex 11)
Audit & Inspection Readiness
Prepare for regulatory inspections, customer audits and partner due diligence with confidence rather than last-minute firefighting.
- Mock inspections led by experienced auditors
- Inspection readiness plans, storyboards and front/back-room set-up
- Staff coaching on interview conduct and document requests
- Response strategy and CAPA support for observations (e.g. FDA Form 483)
SOPs & Quality Manuals
Clear, usable procedures written for the people who follow them — compliant, consistent and easy to maintain.
- New SOP suites for start-ups and new facilities
- Rewrite and harmonisation of existing procedures
- Work instructions, forms and templates
- Periodic review and document lifecycle management
Vendor Qualification & Oversight
Your suppliers and outsourced partners are an extension of your quality system. We help you qualify and oversee them on a risk basis.
- Supplier and CMO/CDMO audits
- Risk-based vendor qualification programmes
- Quality agreements and approved supplier lists
- Ongoing performance monitoring and re-qualification
Interim & Fractional QA Leadership
Experienced quality leaders to step in while you recruit, scale or navigate a critical period such as an inspection or product launch.
- Interim QA Director or QA Manager
- Fractional quality leadership for early-stage companies
- Staff augmentation for QA projects and backlogs
- Mentoring and building your in-house QA team
A Clear, Practical Approach
Assess
We review your current systems, documents and practices against the regulations and guidance that apply to you, and agree priorities with you.
Plan
You receive a prioritised, risk-based plan with clear deliverables, owners and timelines — no generic templates.
Implement
We work alongside your team to build processes, write documents, run audits and close gaps, remotely or on site.
Sustain
We train your people, hand over ownership and remain available for periodic reviews, audits and interim support.
Built for Growing Life-Science Companies
- Start-ups and virtual biotechs building a quality system for the first time
- Companies preparing for a pre-approval, routine or for-cause inspection
- Organisations entering new markets across Canada, the US, the UK or the EU
- Sponsors overseeing CROs, CMOs and other outsourced partners
- Teams that need senior QA leadership while they recruit or scale
Experience That Shows in the Details
- Senior consultants with decades of combined pharmaceutical QA and regulatory experience
- Industry backgrounds including Mylan, Auro Pharma, AstraZeneca, Pfizer and GSK
- ISO 9001 Lead Auditor and Lean Six Sigma Green Belt certified leadership
- Team coverage across Canada, the United States, the UK and the EU
- Right-sized advice that fits your stage, budget and timelines
Common Questions About QA Consulting
When should a start-up put a quality management system in place?
As early as your first GxP activity — typically before non-clinical studies, clinical trial supply or manufacturing begins. Starting with a lean, phase-appropriate QMS is far easier and cheaper than retrofitting one before an inspection or partnering deal.
What is a mock inspection and how long does it take?
A mock inspection simulates a regulatory inspection of your site or processes, using the same approach an FDA, Health Canada, MHRA or EU inspector would. Depending on scope, it usually takes one to three days on site or remotely, followed by a written report with findings graded by risk and practical recommendations.
Can you support us remotely?
Yes. Most QMS development, document writing, gap assessments and vendor oversight can be delivered remotely. Audits and mock inspections can be performed on site or remotely, and we are available for international travel when needed.
Do you work with our existing QMS software?
Yes. Our consultants have worked with electronic quality systems such as TrackWise and Documentum, and we adapt to the tools you already use rather than asking you to change platforms.
How are engagements priced?
We offer fixed-fee projects for defined deliverables (for example, a gap assessment or SOP suite), and day-rate or retainer arrangements for ongoing support and interim leadership. We agree scope and fees up front after a free discovery call.
Often Combined With
2026 GxP Inspection Readiness Checklist
A practical self-assessment covering eight areas inspectors focus on — from data integrity and CAPA to inspection logistics — plus a 90-day readiness timeline.
Let's Talk About Your Quality System
Have a compliance challenge or regulatory question? We'd love to hear from you. Fill in the form or reach us directly.