Sharlin Consulting
Sharlin Consulting, LLC
Sharlin Consulting – Expert FDA Regulatory & 510(k) Consulting
Sharlin Consulting is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies through their regulatory journey. With extensive experience, they offer expertise in navigating complex FDA requirements.
Buyer Snapshot
Best for
- Companies needing expert analysis of FDA compliance issues.
- Organizations requiring a deep dive into drug/medical device safety data.
- Businesses seeking insights from a former FDA reviewer.
How engagement typically works
- Consultative analysis of regulatory and compliance matters.
- Expert interpretation of safety data and FDA compliance information.
Typical deliverables
- Expert analysis reports.
- Guidance on FDA compliance and regulatory affairs.
Good to know
- Best when requiring specialized insight into FDA regulatory and compliance challenges.
HQ:
EU
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
25
Num510k Submitted:
75
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, neurology, orthopedic, gastroenterology, urology
Technology Types:
Software Development, Data Integrity
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Engagement Models:
Regulatory affairs consultant, Expert witness
