ProPharma Group
FDA Regulatory Consultants: 510(k), De Novo, PMA for Medical Devices. Global Reach.
ProPharma Group is a full-service CRO specializing in FDA regulatory consulting for medical devices. With 15 years of experience, they offer comprehensive support for 510(k) (traditional), De Novo, and PMA submissions, serving clients globally. Their expertise extends to Class I and Class II devices, particularly within the general hospital specialty, helping companies navigate complex regulatory pathways and achieve successful clearances in the US, EU, and beyond.
Buyer Snapshot
Best for
- Companies seeking FDA regulatory consulting for medical devices and pharmaceuticals.
- Businesses needing support with European market entry and regulatory compliance.
- Organizations requiring expert guidance for FDA meetings and submissions.
How engagement typically works
- Bespoke/custom solutions tailored to client needs.
- Strategic partnership across the product lifecycle.
- Global reach with local expertise.
Typical deliverables
- FDA submission strategies and authoring.
- FDA meeting preparation and execution.
- European regulatory strategy and submissions.
- Marketing Authorization Holder services.
- Expert witness testimony and litigation support.
Good to know
- Best when requiring deep regulatory expertise for complex submissions.
- Ideal for companies navigating both US FDA and European regulatory landscapes.
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, Predicate Research & Substantial Equivalence Strategy, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
Medical device
Years Experience:
15
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
fixed_fee
Accepting New Clients:
No
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Provides Submission Project Management:
Yes
Supports Labeling Review:
Yes
