Pharmaceutical Regulatory Affairs Consulting
From first regulatory strategy to approval and beyond, we help pharmaceutical and biotech companies plan, prepare and manage submissions with the FDA, EMA, MHRA and Health Canada — and get to market with fewer surprises.
Regulatory decisions made early in development shape timelines, budgets and valuation for years. The wrong pathway, an incomplete CMC package or a poorly prepared health authority meeting can add months to a programme. The right strategy, set early and executed well, turns regulation into a predictable part of your plan.
Radical Pharma Consultancy brings together senior regulatory professionals with hands-on experience across North America and Europe. Our team has prepared and managed submissions at companies including Mylan, AstraZeneca, Pfizer and GSK, covering eCTD publishing, EU and UK marketing authorisation applications, CMC strategy and US labelling.
We work as an extension of your team: setting strategy, writing and reviewing dossier content, preparing for agency interactions and keeping approved products compliant throughout their lifecycle.
Regulatory Affairs Services
Regulatory Strategy & Roadmaps
A clear, evidence-based plan for how your product reaches each target market.
- Pathway assessment for the US, Canada, UK and EU
- Development and submission roadmaps with key milestones
- Regulatory risk assessment for programmes and assets
- Target product profile and labelling strategy input
Submissions: IND, NDA, MAA & Health Canada
Planning, authoring, review and management of clinical and marketing applications.
- FDA IND and NDA preparation and maintenance
- EU and UK marketing authorisation applications (MAA)
- Health Canada clinical trial and drug submissions
- Responses to agency questions and deficiency letters
eCTD & Submission Management
Well-structured, compliant dossiers that reviewers can navigate easily.
- eCTD structure, granularity and lifecycle planning
- Document authoring and quality review against ICH M4 (CTD)
- Submission tracking and regulatory information management
- EU product data requirements (e.g. EVMPD/xEVMPD)
CMC Regulatory Support
Chemistry, manufacturing and controls content that supports approval and future change.
- Module 3 authoring and review
- CMC strategy for small molecules and biologics
- Post-approval changes: variations and supplements
- Lifecycle management and renewals
Designations & Health Authority Meetings
Make the most of every interaction with regulators.
- FDA and EMA orphan drug designation applications
- Pre-IND and FDA Type A, B and C meeting preparation
- EMA scientific advice and MHRA meeting support
- Briefing packages, rehearsal and meeting minutes
Labelling & Structured Product Labeling
Accurate, compliant product information across markets.
- US prescribing information and SPL
- EU SmPC and patient information leaflets
- Labelling change management and alignment
- Artwork and packaging text review
From Strategy to Approval
Assess
We review your product, data and goals, and map the regulatory pathways and requirements for each target market.
Strategise
You receive a regulatory plan with timelines, risks and agency interaction points, aligned with your business milestones.
Prepare & Submit
We author, review and compile dossier content, prepare meeting packages and manage submissions through to acknowledgement.
Maintain
We handle agency questions, post-approval changes, renewals and labelling updates to keep your product compliant.
Who We Support
- Biotech start-ups planning their first IND or clinical trial application
- Companies preparing NDA, MAA or Health Canada marketing submissions
- Sponsors expanding an approved product into new markets
- Organisations with lean regulatory teams needing senior expertise
- Companies managing post-approval changes and lifecycle activities
Regulatory Expertise Across Three Continents
- Experience with FDA, EMA, MHRA and Health Canada frameworks
- Regulatory careers at Mylan, AstraZeneca, Pfizer, GSK, Janssen and Sanofi
- Specialist depth in eCTD, CMC, biologics and EU/UK MAA submissions
- A team member recognised with the FDA Commissioner's Special Citation for work on the HL7 Structured Product Labeling standard
- Practical, right-sized support for start-ups and mid-sized companies
Common Questions About Regulatory Affairs Consulting
When should we involve a regulatory consultant?
Ideally before key development decisions are locked in — for example when choosing indications, designing pivotal studies or planning CMC. Early regulatory input avoids costly rework and helps you use agency meetings and designations to your advantage.
Can you manage submissions in more than one region at the same time?
Yes. With team members in Canada, the United States and the United Kingdom, we plan multi-regional submissions so that data, documents and timelines are aligned across the FDA, EMA, MHRA and Health Canada wherever possible.
Do you publish eCTD submissions?
We plan eCTD structure and lifecycle, author and review content, and can coordinate publishing with your chosen publishing vendor or in-house team so the final dossier is compliant and reviewer-friendly.
Can you help us prepare for an FDA or EMA meeting?
Yes. We help you decide when to request a meeting, draft the briefing package and questions, rehearse your team and document the outcomes and next steps.
How are regulatory projects priced?
We offer fixed-fee pricing for defined deliverables such as a regulatory strategy or a meeting package, and day-rate or retainer arrangements for ongoing submission support. Scope and fees are agreed up front after a free discovery call.
Often Combined With
Let's Talk About Your Regulatory Plans
Have a compliance challenge or regulatory question? We'd love to hear from you. Fill in the form or reach us directly.