ProPharma Group

ProPharma Group

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 ...

Experience: 15+ years

Submissions: 10 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPma

Device Specialties

General-Hospital

Regions Served

ProPharma Group provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Executive Summary

Professional Overview

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...

Core Specializations

Regulatory Pathways

510kDe NovoPma

Device Specialties

General-Hospital

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Regions: US, EU
  • Background: 15+ years of regulatory experience.

Cruxi view

ProPharma Group stands out as a full-service CRO with a large regulatory sciences group, offering comprehensive support for medical device companies. With 15 years of experience, they specialize in navigating complex FDA regulatory pathways, including 510(k) (traditional), De Novo, and PMA submissions for Class I and Class II devices, particularly within the general hospital specialty. Their global reach, serving clients in the US, EU, and beyond, combined with their extensive expertise, positions them as a robust partner capable of providing end-to-end regulatory strategy and execution.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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