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 Certified | FDA Health Canada EU | Drugs Devices BLA
100%
Job Success
Brampton, Canada - 9:09 pm local time
Regulatory documentation either moves your filing forward or it doesn't. I make sure it does.
I'm a RAC-Drugs certified Regulatory Affairs consultant with 4+ years of hands-on experience supporting pharma, biotech, and medtech teams across FDA, EMA, Health Canada, CDSCO, and ICH frameworks. I deliver submission-ready documentation — not drafts that need rework.
Most regulatory documents fail not because of bad science, but because they're poorly structured, inconsistently formatted, or not written to how reviewers actually think. That's the gap I close.
What I Deliver:
— IND/CTA and NDA/ANDA module drafting (Modules 2–5)
— eCTD structure, publishing, and sequence preparation
— Clinical writing: Protocols, IBs, CSRs, safety summaries
— Labeling: USPI, SmPC, CCDS review and compliance
— Regulatory gap analysis and audit readiness
— SOPs, QA systems, CAPA documentation
— Health Canada submissions and compliance strategy
— MDR/IVDR: CERs, PERs, and technical file support
Why Clients Choose Me:
— RAC-Drugs certified — validated expertise, not self-declared
— Top Rated Plus with 100% Job Success Score across all engagements
— Structured, defensible documentation delivered on timeline
— Direct, senior-level execution — no juniors, no handoffs
— Built for lean teams and tight regulatory deadlines
If your regulatory documentation needs to be submission-ready — not just technically complete — send me your project brief. I respond within hours and I don't deliver work that needs rework.
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.