Quality & Regulatory Support for Start-Ups
Build the right quality and regulatory foundations from day one — lean enough for your stage, strong enough for regulators, investors and partners.
Early-stage life-science companies face a difficult balance. Too little quality and regulatory structure creates risk that surfaces at the worst moment — during a clinical trial application, an investor's due diligence or a partner's audit. Too much structure consumes scarce cash and slows the science.
Radical Pharma Consultancy specialises in right-sized solutions for start-ups. We help you put in place a phase-appropriate quality system, a realistic regulatory roadmap and the documentation that investors and partners expect to see, without building a large in-house team before you need one.
As your company grows, our support grows with you, from a handful of SOPs to full GxP compliance and fractional leadership.
Start-Up Services
Quality System Set-Up
A lean, phase-appropriate quality management system that can scale.
- Core SOPs: document control, training, deviations, CAPA and change control
- Quality manual and quality policy
- Selection and set-up of simple, scalable QMS tools
- Oversight model for virtual and outsourced operations
Regulatory Roadmaps
A clear path from where you are today to your first submission and beyond.
- Regulatory pathway options for the US, Canada, UK and EU
- Development plan and milestone timelines
- Early agency interaction and designation opportunities
- Budget-aware prioritisation of regulatory activities
Due Diligence Support
Be ready for investors, acquirers and licensing partners — or assess a target yourself.
- Quality and regulatory data room preparation
- Readiness reviews before partner audits
- Technical due diligence on assets and partners
- Clear summaries of risks and mitigations
Outsourcing & Vendor Oversight
Choose and manage CROs, CMOs and laboratories with confidence.
- Vendor selection criteria and qualification
- Quality agreements
- Risk-based audit planning
- Ongoing performance oversight
Fractional QA / RA Leadership
Senior expertise a few days a month, until you need a full-time leader.
- Fractional Head of Quality or Regulatory
- Board and investor updates on quality and regulatory status
- Mentoring your first QA and regulatory hires
- Support recruiting your permanent team
How We Work With Start-Ups
Understand
We learn about your product, stage, funding milestones and partners, so our advice fits your real priorities.
Roadmap
You receive a practical plan covering the quality and regulatory work needed for your next milestones — and what can wait.
Build
We put the essential systems and documents in place, working alongside your team and vendors.
Scale
As you grow, we expand your systems, support inspections and submissions, and help you build your own team.
Who We Support
- Pre-clinical and early clinical-stage biotech companies
- Virtual companies that outsource development and manufacturing
- Founders preparing for seed, Series A or later funding rounds
- Academic spin-outs moving from research to regulated development
- Start-ups preparing for a licensing or partnering deal
Start-Up Friendly by Design
- Practical, right-sized solutions rather than big-company templates
- Senior expertise without the cost of a full-time executive
- Experience across Canada, the US, the UK and the EU
- Flexible engagement models that match your cash runway
- Advice that holds up to investor, partner and regulator scrutiny
Common Questions From Start-Ups
How much quality system do we need at the pre-clinical stage?
Less than many founders fear, but more than none. At minimum you need controlled documents, training records, deviation handling and oversight of the vendors running GLP studies or manufacturing for you. We help you put the essentials in place and add to them as you approach clinical trials.
What do investors look for in quality and regulatory due diligence?
Typically a credible regulatory strategy, evidence that studies and manufacturing were performed under appropriate standards, qualified vendors, and records that are complete and traceable. We help you organise this before the data room opens.
Can you work with our CRO and CMO?
Yes. We act on your behalf to qualify and oversee vendors, review their documentation and make sure your quality agreements clearly define responsibilities.
We cannot afford a full-time head of quality. What are our options?
Fractional leadership gives you a senior quality or regulatory lead for a set number of days per month. It provides the oversight and accountability regulators and investors expect at a fraction of the cost.
How are start-up engagements priced?
We offer fixed-fee packages for defined deliverables, such as a QMS starter set or a regulatory roadmap, and flexible monthly arrangements for ongoing support. We start with a free discovery call.
Often Combined With
Let's Talk About Your Start-Up
Have a compliance challenge or regulatory question? We'd love to hear from you. Fill in the form or reach us directly.