You will get An 'Ex-Regulator' Audit of your Dossier (CTD/eCTD/ACTD)
Project details
Worried about what regulators will find in your dossier?
I'm an ex-Lead Regulatory Assessor (9+ yrs) from a GCC health authority. I've assessed thousands of CTD/eCTD dossiers and served on the National Clinical Trials Committee and Ethical Review Board. I know every "point of failure" because my job was to find them.
What This Project Delivers: A pre-submission "Mock Review" of your dossier (CTD/eCTD/ACTD) from the regulator's perspective. I find the critical scientific and logical flaws before you submit.
My Review Covers:
Module 3 (CMC): Full 3.2.S & 3.2.P review.
Module 2.3 (QOS): Consistency with M3.
Module 5 (Clinical/BE): Review of BE studies (5.3.1) or clinical reports.
Your Deliverables:
Gap Analysis Report: A detailed report identifying all Critical, Major, and Minor deficiencies.
Actionable Remediation Plan: Clear steps on how to fix every issue, citing correct (ICH, FDA, EMA, GCC, ASEAN) guidelines.
1-on-1 Consultation: A 60-minute debrief call to discuss my findings.
Stop guessing what your assessor is thinking. Hire one. De-risk your submission, prevent costly delays, and get to market faster.
I'm an ex-Lead Regulatory Assessor (9+ yrs) from a GCC health authority. I've assessed thousands of CTD/eCTD dossiers and served on the National Clinical Trials Committee and Ethical Review Board. I know every "point of failure" because my job was to find them.
What This Project Delivers: A pre-submission "Mock Review" of your dossier (CTD/eCTD/ACTD) from the regulator's perspective. I find the critical scientific and logical flaws before you submit.
My Review Covers:
Module 3 (CMC): Full 3.2.S & 3.2.P review.
Module 2.3 (QOS): Consistency with M3.
Module 5 (Clinical/BE): Review of BE studies (5.3.1) or clinical reports.
Your Deliverables:
Gap Analysis Report: A detailed report identifying all Critical, Major, and Minor deficiencies.
Actionable Remediation Plan: Clear steps on how to fix every issue, citing correct (ICH, FDA, EMA, GCC, ASEAN) guidelines.
1-on-1 Consultation: A 60-minute debrief call to discuss my findings.
Stop guessing what your assessor is thinking. Hire one. De-risk your submission, prevent costly delays, and get to market faster.
Document Type
ReportTopic
Biotechnology, Manufacturing, Medical, Science, TechnologyLanguage
English, FilipinoWhat's included $1,000
These options are included with the project scope.
$1,000
- Delivery Time 7 days
- Number of Revisions 1
- Consultation
- Additional Research
- References & Citations
Optional add-ons
You can add these on the next page.
Additional Revision
+$100
Expedited 4-Day Delivery
+$500Frequently asked questions
About Mhed
Global Regulatory Affairs Consultant (CMC/Clinical/BE) | Ex-Regulator
Paranaque City, Philippines - 9:00 am local time
During my time as an assessor, I was the primary technical SME for all complex CMC, Clinical, and Bioequivalence matters, and served as a key member of the National Clinical Trials Committee and Ethical Review Board. I have personally assessed—and know why clients fail—thousands of CTD and eCTD dossiers and clinical trial applications for the GCC region.
Now, I combine this deep "regulator-side" expertise with direct, hands-on industry experience.
My Core Competencies:
GCC/MENA Expertise (Ex-Regulator): Unmatched "regulator-side" insight into the GCC submission and approval process. I know exactly what assessors look for.
Clinical Trial & Ethics Expertise: As a former member of the National Clinical Trials Committee and Ethical Review Board, I am an expert in de-risking clinical trial applications (CTAs) and navigating complex ethical/safety reviews.
ASEAN Expertise (Consultant): Direct, hands-on experience in preparing, optimizing, and remediating ACTD dossiers for the Philippines and other ASEAN markets.
Global Regulatory Strategy (ICH/USFDA): Deep knowledge of global standards (ICH, USFDA) and how to bridge the gap between a core CTD and specific regional submission requirements (ACTD/GCC).
Health Authority Interaction: Proven 100% success rate in resolving complex regulatory queries.
Services Offered:
Clinical Trial Application (CTA) Review & De-Risking
CTD / ACTD Dossier Review & Gap Analysis
CMC Module 3 Authoring & Remediation
Regulatory Query Response Authoring (ASEAN, GCC, MENA)
Pre-submission "Mock-Reviews"
I am available for high-impact remote consulting projects, specializing in de-risking your portfolio for the US, ASEAN, GCC, and MENA regions.
Steps for completing your project
After purchasing the project, send requirements so Mhed can start the project.
Delivery time starts when Mhed receives requirements from you.
Mhed works on your project following the steps below.
Revisions may occur after the delivery date.
Kick-off & Secure File Transfer
You will provide your complete dossier (CTD/eCTD/ACTD) and any required NDA through our secure Upwork contract room so I can begin my review.
In-Depth "Ex-Regulator" Mock Review
I will conduct my comprehensive review of your files (M2.3, M3, M5), identifying all critical/major/minor deficiencies and "points of failure" from an assessor's perspective.