Expert Guidance in
QA & Regulatory Affairs
We help pharmaceutical and biotech companies navigate complex regulatory environments, build robust quality systems, and achieve compliance with confidence — across the US, Canada, the UK, the EU and India.
A Trusted Partner in Pharmaceutical Compliance
We are a pharmaceutical consultancy specialising in Quality Assurance and Regulatory Affairs. Our mission is to help companies — from startups to mid-sized organisations — navigate the complexities of pharmaceutical regulation with clarity and confidence.
Whether you need support preparing for a health authority inspection, developing quality systems, or managing regulatory submissions, we bring deep expertise and a hands-on approach tailored to your needs.
FDA & EMA Experience
Deep knowledge of US and European regulatory frameworks
GxP Expertise
GMP, GCP, GLP — we cover the full compliance spectrum
Startup Friendly
Practical, right-sized solutions for growing businesses
Global Reach
Remote and on-site support available worldwide
Our Core Services
Comprehensive consulting services across the full quality and regulatory spectrum.
Providing simple solutions to complex problems.
Quality Assurance
Building and strengthening quality systems to meet global GxP standards and audit requirements.
- QMS Development & Review
- GMP / GCP / GLP Compliance
- Audit & Inspection Readiness
- SOPs & Quality Manuals
- Vendor Qualification & Oversight
Regulatory Affairs
Strategic guidance on regulatory submissions, health authority interactions, and market access.
- FDA & EMA Submissions
- IND / NDA / MAA Preparation
- Orphan Drug Designations
- Regulatory Strategy
- Health Authority Meeting Support
Compliance & Risk
Identifying gaps and implementing risk-based solutions to keep your operations compliant.
- Gap Assessments
- Risk Management Plans
- Compliance Training
- Policy & Procedure Development
- Mock Inspections
Interim Leadership
Experienced interim QA/RA leaders available for fractional or full-time engagements.
- Interim QA Director / Manager
- Fractional Head of Regulatory
- Staff Augmentation
- Team Mentoring & Training
Start-Up Support
Tailored solutions for early-stage companies building their quality and regulatory foundation.
- Quality System Set-Up
- Regulatory Roadmaps
- Due Diligence Support
International Compliance
Supporting multi-regional regulatory strategies across US, EU, and global markets.
- ICH Guidelines Implementation
- Multi-regional Submissions
- Cross-border Audit Support
- Global Regulatory Intelligence
The Experts Behind Radical Pharma
A senior team with deep expertise across Canada, the United States, and Europe — delivering practical, high-impact regulatory and quality solutions wherever you need them.
Umesh Panchal
Umesh is the Founder of Radical Pharma Consultancy Inc., bringing over 20 years of experience in Quality Assurance and Regulatory Affairs across the pharmaceutical industry. With a career spanning Mylan UK, Mylan Canada, and Auro Pharma, he has deep expertise in GMP/GxP compliance, FDA and Health Canada regulatory frameworks, and quality system development. Umesh is passionate about helping startups and mid-sized companies build robust compliance foundations and navigate complex regulatory environments with confidence.
LinkedIn Profile
Michelle Mc Guinness
Michelle is the Founder of Pharmaceutical Compliance Partners, LLC, with extensive expertise in Regulatory Affairs, Quality Assurance and Commercial Compliance. A former Senior Director at AstraZeneca, she has held leadership roles at Janssen, Mylan, Sanofi, and J&J. She holds an MSc in QA/Regulatory Affairs from Temple University and has been recognised with the FDA Commissioner's Special Citation for her contributions to the HL7 Structured Product Labeling standard.
LinkedIn Profile
Jitendra Patil
Jitendra is a UK-based Regulatory Affairs Consultant with over 15 years of experience across the British and European pharmaceutical industry. He has held senior roles at AstraZeneca, Pfizer, GlaxoSmithKline, MSD, UCB, and Dr Reddy's, specialising in CMC regulatory strategy, biologics drug development, EU/UK MAA submissions, and post-approval lifecycle management. He holds an MSc in Pharmaceutical Science from Kingston University, London.
LinkedIn ProfileThe Right Partner at Every Stage
Deep Industry Expertise
Our consultants have hands-on experience across pharmaceutical, biotech, and medical device sectors, with a thorough understanding of FDA, EMA, and global regulatory requirements.
Practical, Right-Sized Solutions
We don't deliver generic advice. Every engagement is tailored to your company's size, stage, and specific challenges — delivering solutions that actually work in practice.
Flexible Engagement Models
From short-term project support to long-term fractional leadership, we adapt to your needs — available remotely, locally, or for international travel assignments.
Proven Track Record
Our clients consistently achieve successful audits, regulatory approvals, and streamlined quality operations — because we treat your goals as our own.
Ready to strengthen your compliance posture?
Whether you're preparing for an FDA inspection, building a quality system from scratch, or need interim regulatory leadership — we're here to help. Let's start with a free discovery call.
Book a Free 20-Min Call2026 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 Work Together
Have a compliance challenge or regulatory question? We'd love to hear from you. Fill in the form or reach us directly.