12+ Years · Regulatory Affairs CMC
Edward Regulatory
Consulting
Expert CMC regulatory strategy across submission, clinical trials, and pre- & post-approval lifecycle. Turning complex dossiers into first-cycle approvals for FDA and EMA.
Core Expertise
Depth across the full CMC regulatory lifecycle
CMC Submissions
Authoring and lifecycle management of CMC dossiers (Module 3, eCTD) for INDs, NDAs, MAAs and variations across FDA and EMA.
Clinical Trials
CMC support for IND/IMPD filings, trial-phase appropriate documentation, and CTA maintenance through development.
Pre & Post Approval
Strategy through approval and beyond — variations, change control, supplements and post-market commitments.
Submission Readiness
Dossier health checks, gap closure and agency-meeting preparation to ensure first-cycle approval confidence.
About
Hannah Edward
Fractional CMC Regulatory Affairs Consultant
With over twelve years dedicated to Chemistry, Manufacturing and Controls (CMC) regulatory affairs, I help biotech and pharmaceutical teams navigate the most technically demanding parts of the submission journey — from first-in-human through marketing approval and beyond.
My focus spans submission authoring, clinical trial CMC support, and pre- and post-approval lifecycle management. I partner closely with quality, manufacturing and clinical teams to build dossiers that withstand FDA and EMA scrutiny — and to close the gaps that delay approvals.
“Submission readiness isn’t a milestone — it’s a discipline. My job is to make sure nothing surprises you, and nothing surprises the agency.”
Services
From gap to green light
Three focused engagements designed to de-risk your regulatory path — whether you need a diagnostic, an action plan, or a strategy to brief your board.
Gap Analysis
Know exactly where you stand
A rigorous, line-by-line review of your CMC dossier and quality documentation against current FDA/EMA expectations — surfacing deficiencies before the agency does.
- Module 3 / eCTD completeness review
- Health-authority guidance benchmarking
- Risk-rated findings register
- Prioritised, evidence-based summary
Remediation Roadmap
A clear path to compliant
A sequenced, resourced action plan that turns gaps into closed items — with owners, timelines and submission-ready deliverables.
- Prioritised remediation backlog
- Owner & timeline mapping
- Submission-ready deliverables
Regulatory Strategy Brief
Decisions, de-risked
A concise, board-ready strategy document outlining the optimal regulatory pathway, agency interactions and CMC milestones for your asset.
- Pathway & filing strategy
- Agency engagement plan
- CMC milestone mapping
Results Delivered
Measurable impact across global portfolios
Experience
A decade-plus of regulatory milestones
Twelve years building, defending and advancing CMC submissions across the full product lifecycle.
Allergan
CMC regulatory affairs — authoring and maintaining submission documentation and supporting lifecycle activities across the product portfolio.
Pfizer · Regional Regulatory CMC
Regional CMC regulatory affairs across multi-market portfolios spanning solid dose, biologics and sterile products.
Pfizer · Regulatory CMC (RCM)
Drove a 25% reduction in PDM update cycle time through process redesign; led a team of eight delivering 617+ Fragmin submissions to Health Authorities (2021–2023); and contributed to CMC post-approval submissions for the COVID-19 vaccine booster programme.
Viatris
Delivered a 15% reduction in drug portfolio maintenance cycle time, supporting global submissions across EMEA, US, Canada, APAC and Latin America.
Edward Regulatory Consulting
Independent fractional CMC regulatory affairs consultant — advising biotech and pharma on submission strategy, gap analysis, remediation roadmaps and pre & post-approval lifecycle management.
Book a Consultation
Let’s talk about your submission
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