You will get a submission ready gap analysis report
Top Rated
Top Rated
Project details
Your regulatory program doesn't fail because of bad science. It fails because the gap between where your documentation is and where it needs to be isn't clearly mapped. That's exactly what this service delivers.
As a RAC-Drugs certified consultant with 4+ years across FDA, Health Canada, EMA, CDSCO, and ICH frameworks — I conduct a systematic, structured review of your existing regulatory documentation and deliver a written gap analysis report that tells you exactly what's missing, what needs fixing, and in what order to address it.
What you receive:
✔ Written gap analysis report (PDF + Word)
✔ Compliance matrix against target framework
✔ Prioritized action items — critical, major & minor
✔ Reviewer-ready language throughout
✔ One revision round included
This is not a generic checklist. This is senior-level regulatory review built around your specific product, development stage, and target agency.
Message me before ordering to confirm scope fit. I respond within hours.
As a RAC-Drugs certified consultant with 4+ years across FDA, Health Canada, EMA, CDSCO, and ICH frameworks — I conduct a systematic, structured review of your existing regulatory documentation and deliver a written gap analysis report that tells you exactly what's missing, what needs fixing, and in what order to address it.
What you receive:
✔ Written gap analysis report (PDF + Word)
✔ Compliance matrix against target framework
✔ Prioritized action items — critical, major & minor
✔ Reviewer-ready language throughout
✔ One revision round included
This is not a generic checklist. This is senior-level regulatory review built around your specific product, development stage, and target agency.
Message me before ordering to confirm scope fit. I respond within hours.
Project Type
Business Consulting, LegalWhat's included
| Service Tiers |
Starter
$499
|
Standard
$999
|
Advanced
$1,299
|
|---|---|---|---|
| Delivery Time | 5 days | 7 days | 10 days |
Number of Revisions | 1 | 2 | 2 |
Optional add-ons
You can add these on the next page.
Fast Delivery
+$200 - $250
Additional Revision
+$150
30-Minute Strategy Call
+$150Frequently asked questions
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About Shaheen Fathima
RAC-Drugs (Global) | Regulatory Medical Writer | FDA | EU MDR/IVDR
100%
Job Success
Brampton, Canada - 8:32 pm local time
Regulatory documentation that holds up under Notified Body and health authority scrutiny — that's the standard I work to.
I'm a RAC-Drugs (Global) and ICH-GCP certified Regulatory Affairs Consultant and Medical Writer with 4+ years of direct, senior-level execution across pharmaceutical, biologic, medical device, IVD, SaMD, vaccine, combination product, cosmetic, and dietary supplement programs spanning FDA, EMA, Health Canada, CDSCO, TGA, PMDA, MHRA, SwissMedic, and GCC regulatory frameworks.
Strong science doesn't move submissions forward on its own. What moves them is documentation that's technically accurate, strategically positioned, and built to how health authorities actually evaluate safety, efficacy, quality, and compliance. That's where I add value — especially when a submission has already been refused, rejected, or flagged.
SUBMISSION REMEDIATION & REGULATORY CRISIS RESPONSE
20+ regulatory refusal, inspection, and non-compliance response cases across seven health authorities:
— FDA: 8–10 Form 483 responses; 4 ANDA RTR; 4 RTF (3 NDAs, 1 BLA/biologic); 2 RTA (510(k) device, De Novo drug)
— FDA ODD: Remediated a rejected dual-indication ODD for a rare CNS condition — strategic repositioning and evidence restructuring to achieve submission readiness
— Health Canada: Inspection Exit Notice + Report of Findings
— EU: 6 Statements of Non-Compliance
— TGA: 2 GMP Inspection Report responses
— SwissMedic: Inspection Report (Non-Conformities/Deficiencies)
— MHRA: Inspection Report (Critical, Major, and Other deficiency classifications)
CLINICAL EVALUATION & SYSTEMATIC LITERATURE REVIEW — EU MDR/IVDR
Authored CER literature reviews and SOTA sections for 5 regulated products across 3 device classifications — including 2 solo-authored SLRs — all Notified Body or Health Canada reviewed. Scope: Class IIa active physiological monitoring devices (EU MDR 2017/745, Rule 10); Class B self-test IVDs (EU IVDR 2017/746, Rule 4); Class C diagnostic IVDs (EU IVDR 2017/746, Rule 4); Health Canada Class II. PRISMA-documented searches across PubMed/MEDLINE, Embase, Cochrane — aligned to MEDDEV 2.7/1 Rev 4, MDCG 2020-6, MDR Annex XIV.
CORE SERVICES
— Submission remediation: FDA 483, RTF/RTR/RTA, ODD, Statements of Non-Compliance, GMP inspection reports — FDA, EMA, HC, TGA, MHRA, SwissMedic
— CER, PER, SLR, SOTA — EU MDR/IVDR, Health Canada
— IND/CTA/NDA/ANDA/BLA documentation (Modules 2–5), eCTD publishing
— Clinical writing: protocols, IBs, CSRs, safety summaries
— Global labeling: USPI, SmPC, Canada PM, Australia PI, Japan IF
— Combination products: inhalers, auto-injectors, drug-device combinations
— Cosmetics: MoCRA, CPNP, UK CPSR, TGA, Health Canada SOR/2016-169
— Dietary supplements: FDA DSHEA, EU notifications (5 member states)
— Health Canada MDEL/MDL, therapeutic claim reclassification
— Regulatory strategy, gap assessments, SOPs, CAPA
TRACK RECORD
— 20+ refusal and inspection cases — FDA, EMA, HC, TGA, MHRA, SwissMedic — including BLA RTF, De Novo RTA, rejected ODD remediation for rare CNS dual-indication
— 5 CER/SLR projects across EU MDR and EU IVDR — all NB or HC reviewed
— Dietary supplement notifications across 5 EU member states + FDA DSHEA
— HC MDEL/MDL for consumer product reclassified as Class II medical device
— MoCRA cosmetic cross-regional (TGA + MHRA CPSR); CPNP + HC SOR/2016-169
— 4 TGA drug submissions, 2 TGA device submissions, black box labeling
— EpiPen cross-regional program: FDA, EMA, MHRA, TGA — filing through global expansion
— Combination products: inhalers, insulin pen, biologic-coated orthopedic implant — FDA, EMA, TGA, PMDA, HC, GCC
— GCC registrations: UAE, KSA, Oman, Bahrain, Qatar, Kuwait
WHY CLIENTS HIRE ME
— RAC-Drugs (Global) and ICH-GCP certified — validated, not self-declared
— Top Rated Plus, 100% Job Success Score, $40K+ delivered across 13 projects
— Direct senior-level execution — no juniors, no handoffs
— Responsive delivery on fast-moving timelines — including crisis timelines
If you need regulatory documentation and submission strategy that health authorities actually approve — or remediation when they don't — let's talk about your project.
Steps for completing your project
After purchasing the project, send requirements so Shaheen Fathima can start the project.
Delivery time starts when Shaheen Fathima receives requirements from you.
Shaheen Fathima works on your project following the steps below.
Revisions may occur after the delivery date.
Discovery & Scope Confirmation
I review your product details, target agency, and existing documentation to confirm scope and identify the depth of analysis required before work begins.
Regulatory Framework Analysis
Systematic review of your documentation against the target framework — gaps identified and categorized by risk level: critical, major, and minor.