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I will draft your fda 510k premarket submission and classification memo
Licensed US Attorney High Stakes MA Corporate Regulatory Drafting
I am William Leary Halpin, a licensed US Attorney (Bar #3636) specializing in high-stakes transactional, IP, and regulatory law. With extensive experience in complex M&A, corporate structuring, FDA co...
About this Gig
Welcome. I am William Leary Halpin, a licensed US Attorney (Bar #3636). Navigating FDA regulatory frameworks requires absolute precision. A rejected 510(k) submission costs companies months of time and massive revenue.
I provide elite-level regulatory drafting for FDA 510(k) clearances. I translate your clinical and engineering data into legally sound regulatory arguments. Based on your tier, I will draft:
- Device classification memorandums.
- In-depth substantial equivalence arguments.
- Predicate device comparative analysis.
- Full premarket notification submission drafts.
PLEASE NOTE: This is a DRAFTING ONLY service. You must provide all technical, engineering, and clinical data. I will structure the legal and regulatory arguments. I do not act as your US Agent, I do not file the documents with the FDA, and I do not do phone calls.
Field of law:
Business (corporate)
•
International
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Commercial
Legal consulting Gigs are not screened
Please note that there is no screening process for this service. We recommend that you message the freelancer and check all necessary details before placing your order. Pro freelancers in this category have gone through a vetting process. You can find more details here.
FAQ
Do you file the 510(k) for me?
No. I draft the submission documents; you or your regulatory team will submit them to the FDA.
Do I need to provide the technical specs?
Yes. I provide the regulatory drafting, but you must supply the scientific, testing, and engineering data.
Will this guarantee FDA clearance?
No attorney can guarantee FDA clearance. I guarantee a professionally drafted, legally compliant submission based on your data.
Do you act as a US Agent for foreign companies?
No. This service is strictly for document drafting.
Can we hop on a call to discuss the device?
I require all specifications and discussions to be in writing via Fiverr to ensure absolute accuracy in drafting.
