Gayathri Manoj
Regulatory Affairs Professional | 4+ Yrs Exp | 510(k), De Novo, Clinical Trials | Biologics & Medical Devices
Gayathri Manoj is a regulatory affairs professional with over 4 years of experience in biologics, medical devices, and the clinical space. She possesses a proven track record across a diverse range of submissions and strategies, including 510(k), De Novo, and Breakthrough designations, as well as Common Technical Documents (CTDs).
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, Regulatory Pathway Assessment, Device Classification Support, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
4
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
hourly
Accepting New Clients:
Yes
Supports Estar:
Yes
Provides Submission Project Management:
Yes
