Scale Your FDA Consulting Practice
Without the Dossier, eSTAR & Audit Drag!
Stop losing $250+/hr advisory billables to tedious eSTAR formatting, 510(k) administrative assembly, annual establishment registrations, GUDID portal data entry, literature screening for CERs, and QMS version control. SageDoer equips FDA regulatory consultants with vetted, compliance-conscious Virtual Assistants—supervised daily by a Dedicated Project Manager at absolutely no extra charge. Bill premium rates, meet strict CDRH/CDER deadlines, and protect client IP starting at just $6/hour.
Regulatory Ops Pod
Active Submission QA Running
Your Regulatory QA Controller
Audits document formatting against FDA PDF and eSTAR specifications, tracks citation hyperlinks, enforces standard naming conventions, and audits hourly task logs before deliverables reach your desk.
Why Successful FDA Consultants
Choose the SageDoer Managed Model
As a regulatory consultant, your genuine market value lies in strategic pre-sub meetings with CDRH/CDER, drafting clinical justification rationales, and guiding clients through complex 510(k), De Novo, or PMA pathways. You should not be spending 20 hours a week hand-formatting eSTAR XML attachments or building literature review spreadsheets.
Zero Management Overhead
You never have to micromanage unverified remote workers or stress whether technical file version control was executed correctly. Your dedicated Project Manager oversees formatting rigor, timelines, and time logs at no added cost.
Up to 70% Advisory Margin Expansion
Hiring an in-house regulatory affairs associate in the US or EU costs $80,000–$115,000+ plus benefits. Secure vetted, managed regulatory documentation support starting at just $6 to $7 per hour, allowing you to maximize advisory profit margins.
Single Point of Contact
Never waste billable hours coordinating disparate freelancers across scattered channels. Route your submission assembly priorities, literature search protocols, and QMS SOP updates directly to one accountable PM via Slack, Teams, or WhatsApp.
Meticulous Submission Hygiene
A broken hyperlinked citation or malformed PDF bookmark can lead to an administrative Refuse to Accept (RTA) notice from CDRH. Our assistants execute strict pre-submission technical audits to guarantee flawless document structure.
Centralised Time Tracking
Receive auditable, transparent time logs detailing exact minutes spent on each client's 510(k) file, GUDID upload, or literature screening. You can pass clear, documented hours directly through to client invoices.
Zero Downtime Replacement
If an assistant takes leave during a high-stakes FDA submission window or pre-audit remediation sprint, our Project Manager immediately activates an internal backup already trained on your SOPs and filing templates.
What Can You Delegate to an
FDA Regulatory Virtual Assistant?
From 510(k) eSTAR compilation and establishment registration renewals to GUDID entry, literature screening for CERs, and QMS SOP formatting, here is the factual scope our assistants execute daily.
510(k), eSTAR & Pre-Market Submissions
Assembling FDA-compliant submission packages with zero technical formatting errors- eSTAR Template Population: Populating administrative sections, device descriptions, predicate comparisons, and standards conformity tables in CDRH non-IVD and IVD eSTAR PDF forms.
- FDA PDF Specification Conformance: Formatting PDFs according to FDA requirements: Fast Web View enabled, Optical Character Recognition (OCR) applied, bookmarked, and secure font embedding.
- Q-Sub & Pre-Submission Packet Assembly: Compiling background summaries, meeting questions, test protocols, and participant rosters for formal FDA feedback requests.
- 510(k) Summary & Statement Drafting: Formatting predicate comparison matrices, substantial equivalence summary tables, and Indications for Use (FDA Form 3881).
QMS, QMSR & Design History File (DHF) Hygiene
Maintaining audit-ready document systems across ISO 13485 and 21 CFR Part 820- eQMS Document Control (Greenlight Guru, Qualio, MasterControl): Routing Standard Operating Procedures (SOPs), Work Instructions, and change orders (ECO/DCO) through approval workflows.
- Design History File (DHF) & DMR Indexing: Organizing design inputs, design verification protocols, validation reports, and trace matrices into clean, indexed audit binders.
- CAPA & Non-Conformance Log Tracking: Logging corrective action tickets, monitoring root cause investigation deadlines, and preparing status logs for management review meetings.
- Supplier Audit & Approved Vendor List (AVL) Records: Requesting ISO certificates from contract manufacturers, tracking re-evaluation dates, and updating quality agreements.
Establishment Registration, Listing & UDI
Ensuring ongoing compliance on FDA Unified Registration and GUDID portals- FURLS Annual Registration & Device Listing: Managing establishment registration updates, adding new device listings, updating proprietary names, and verifying user fee payments.
- FDA GUDID / UDI Data Entry & Reconciliation: Populating Unique Device Identification (UDI) attributes, DI/PI records, package configurations, and publish dates in the AccessGUDID system.
- US Agent & Foreign Facility Coordination: Logging FEI numbers, DUNS numbers, Official Correspondent details, and tracking annual renewal deadlines.
- Dietary Supplement & Cosmetic MoCRA Filings: Assisting with FDA cosmetic facility registrations, product listings under MoCRA, and food facility biennial renewals.
Literature Reviews (CER), Labeling & Vigilance
Rigorous systematic literature screening and labeling compliance audits- PubMed / Embase Literature Searches: Executing structured search strings for Clinical Evaluation Reports (CER/PER), deduplicating references in EndNote/Mendeley, and screening abstracts.
- FDA Warning Letter & 483 Trend Monitoring: Tracking published FDA warning letters and inspection observations across your clients' specific product categories to flag regulatory risks.
- Medical Device & Supplement Labeling Checks: Auditing product packaging, Instructions for Use (IFU), and website marketing claims against FDA structure/function claim guidelines.
- Post-Market Surveillance & MAUDE Database Searches: Sifting through the FDA MAUDE database to extract adverse event and recall data for similar predicate devices.
Managing multiple device submissions or preparing for a client audit?
We cross-train our managed assistants on your specific regulatory templates, eQMS platforms, and filing formats under strict Non-Disclosure Agreements.
Proficient in Every Critical
FDA Portal, eQMS & Submission Platform
Zero onboarding drag. Our regulatory affairs virtual assistants integrate effortlessly into the specialized FDA portals, quality management systems, and reference databases your consultancy relies on daily.
CDRH eSTAR
510(k) & De Novo FormsFDA ESG Gateway
Electronic SubmissionsGreenlight Guru
MedTech eQMS & DHFVeeva Vault
eTMF & SubmissionsQualio / MasterControl
Document Control & CAPAFDA FURLS
Establishment RegistrationAccessGUDID
Unique Device IDs (UDI)PubMed / NLM
Literature & Clinical TrialsFDA MAUDE
Adverse Event MiningAdobe Acrobat Pro
FDA PDF Specs & BookmarksEndNote / Zotero
CER Reference Management1Password / 2FA
Zero-Credential Sharing
How The SageDoer Managed Model
Integrates With Your Regulatory Practice
A battle-tested 4-phase framework designed specifically for regulatory consultants and advisors who need accurate documentation assembly without hiring headaches.
Submit Requirements
Share your client portfolio, submission targets (510k, De Novo, QMS overhaul), regulatory software (Greenlight Guru, eSTAR, Qualio), and turnaround deadlines. Reach out via:
Finalise the Deal
Our dedicated project manager will promptly get back to you to review your document standards, NDA/confidentiality protocols, client submission SOPs, and finalise partnership details.
Expert Execution
Your dedicated project manager takes full charge of operations, getting the regulatory formatting, eSTAR assembly, and GUDID entries done seamlessly through our internal team of vetted experts.
Pay Only for Output
We log and charge exclusively for the virtual assistant's actual working time. Your dedicated project manager's supervision is completely free.
Traditional Freelance Platforms vs.
The SageDoer Solution
Compare why regulatory affairs consultants, medical device advisory firms, and life science attorneys abandon Upwork, unmanaged contractors, and expensive staffing agencies for SageDoer.
| Feature / Metric | Traditional Platforms | THE SMART CHOICE: SageDoer |
|---|---|---|
| Platform & Management Fees | Up to 40% in hidden markups, bidding, and memberships | 0% Hidden Fees. Pay strictly for hours worked. |
| Daily Team Management | You must juggle and supervise multiple freelancers while auditing technical files | Dedicated Project Manager acts as your single point of contact |
| Quality Assurance | Hit-or-miss talent with no understanding of FDA PDF specs or eSTAR validation | Internally vetted, rigorously trained premium experts |
| Hiring & Deployment Speed | Endless cycles of interviewing and testing candidates during tight client filing deadlines | Instant delegation. We immediately assign the right specialist. |
| Billing & Invoicing | Complex, multi-freelancer invoices with currency headaches | Simple, unified, centralised USD invoicing |
| Staff Turnover & Replacements | Start the hiring and training process all over again | Seamless internal replacements with zero submission disruption |
Simple Rates. Extraordinary Value.
Zero Hidden Markups.
You only pay for the exact hours worked by your virtual assistant. Your dedicated Project Manager’s coordination, supervision, and reporting are completely free.
Part-Time
Ideal for solo FDA consultants managing 3–8 active client dossiers
Est. $560 USD / Month (4 Weeks)
Scale up or pause whenever client submission cycles shift.
Full-Time
Dedicated full-time power for multi-client regulatory consultancies & MedTech firms
Est. $960 USD / Month (4 Weeks)
Maximum savings per hour for high-volume regulatory practices.
Trusted by FDA Consultants, Regulatory Directors & Life Science Advisors
Real experiences from regulatory affairs consultants who reclaimed billable hours, eliminated formatting bottlenecks, and scaled client rosters with SageDoer.
"When preparing Class II medical device 510(k) submissions, populating the non-IVD eSTAR template, checking hyperlinked citations, and ensuring FDA-compliant PDF bookmarks was taking 25 hours per client. SageDoer deployed an assistant in 48 hours. The free PM ensures every document passes RTA technical standards. Total game changer."
Dr. David Bradley, RAC
Principal, Bradley Regulatory Sciences LLC
"At $6/hour full-time, our regulatory consulting group expanded profit margins dramatically. We bill clients $250/hr for high-level regulatory strategy while our SageDoer VA handles annual FURLS establishment registrations, GUDID attribute entry, and Qualio document control. Unbeatable operational leverage."
Soren Kjeldsen
Managing Director, MedTech Compliance Partners
"Zero platform fees and zero recruiting lag. As an independent dietary supplement consultant managing MoCRA compliance and label reviews, tracking ingredient specifications and FDA facility renewals was overwhelming. Having one dedicated PM supervise my VA freed me up to double my client roster."
Aria Valenti
Founder, NutraReg Advisory Services
"During our client's ISO 13485 audit remediation sprint, our primary VA had a personal emergency. SageDoer stepped in with a trained replacement within 24 hours who already knew Greenlight Guru and our CAPA log templates. Zero delayed audit deliverables."
Marcus Rosenthal
Partner, BioDevice Quality & Regulatory Advisors
"When preparing Class II medical device 510(k) submissions, populating the non-IVD eSTAR template, checking hyperlinked citations, and ensuring FDA-compliant PDF bookmarks was taking 25 hours per client. SageDoer deployed an assistant in 48 hours. The free PM ensures every document passes RTA technical standards. Total game changer."
Dr. David Bradley, RAC
Principal, Bradley Regulatory Sciences LLC
"At $6/hour full-time, our regulatory consulting group expanded profit margins dramatically. We bill clients $250/hr for high-level regulatory strategy while our SageDoer VA handles annual FURLS establishment registrations, GUDID attribute entry, and Qualio document control. Unbeatable operational leverage."
Soren Kjeldsen
Managing Director, MedTech Compliance Partners
"Zero platform fees and zero recruiting lag. As an independent dietary supplement consultant managing MoCRA compliance and label reviews, tracking ingredient specifications and FDA facility renewals was overwhelming. Having one dedicated PM supervise my VA freed me up to double my client roster."
Aria Valenti
Founder, NutraReg Advisory Services
"During our client's ISO 13485 audit remediation sprint, our primary VA had a personal emergency. SageDoer stepped in with a trained replacement within 24 hours who already knew Greenlight Guru and our CAPA log templates. Zero delayed audit deliverables."
Marcus Rosenthal
Partner, BioDevice Quality & Regulatory Advisors
Frequently Asked Questions
Real questions from FDA Regulatory Affairs Consultants, Quality Systems Auditors, and Life Science Advisors partnering with SageDoer.
Ready to eliminate document assembly drag and focus on regulatory strategy?
Connect directly with our regulatory affairs practice management team. Submit your client scope requirements below, book a 30-minute consultation call, or reach out instantly via WhatsApp.
Submit Regulatory Requirements
Our dedicated Project Manager will reach back out within 2 business hours.