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.
About
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.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** ProPharma Group
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 10
- **Regions served:** US, EU
- **Client types:** sme, large_medtech
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** ProPharma Group's unique value lies in its dual identity as a full-service CRO and a large, specialized regulatory sciences group, offering integrated, end-to-end support for complex FDA medical device submissions (510(k), De Novo, PMA) with a global perspective.
- **Ideal projects:** The ideal client for ProPharma Group is a medical device company developing Class I or Class II devices, especially those intended for general hospital use, seeking comprehensive FDA regulatory guidance. This includes companies requiring expert assistance with 510(k) clearances, De Novo requests, or PMA submissions, particularly those with aspirations for both US and global market entry. Projects that benefit most are those needing a full-service partner to manage the entire regulatory lifecycle, from strategic planning to successful submission and clearance, leveraging their extensive experience and broad scientific capabilities.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:15:09 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, regulatory strategy
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k, de_novo, pma
- **Type:** firm
- **Company:** ProPharma Group
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 10
- **Regions served:** US, EU
- **Client types:** sme, large_medtech
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** ProPharma Group's unique value lies in its dual identity as a full-service CRO and a large, specialized regulatory sciences group, offering integrated, end-to-end support for complex FDA medical device submissions (510(k), De Novo, PMA) with a global perspective.
- **Ideal projects:** The ideal client for ProPharma Group is a medical device company developing Class I or Class II devices, especially those intended for general hospital use, seeking comprehensive FDA regulatory guidance. This includes companies requiring expert assistance with 510(k) clearances, De Novo requests, or PMA submissions, particularly those with aspirations for both US and global market entry. Projects that benefit most are those needing a full-service partner to manage the entire regulatory lifecycle, from strategic planning to successful submission and clearance, leveraging their extensive experience and broad scientific capabilities.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:15:09 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, regulatory strategy
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k, de_novo, pma
Key Highlights
- 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, positio
- ProPharma Group's unique value lies in its dual identity as a full-service CRO and a large, specialized regulatory sciences group, offering integrated, end-to-end support for complex FDA medical device submissions (510(k), De Novo, PMA) with a global perspective.
Certifications & Trust Signals
- 15 years experience
- 10 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client for ProPharma Group is a medical device company developing Class I or Class II devices, especially those intended for general hospital use, seeking comprehensive FDA regulatory guidance. This includes companies requiring expert assistance with 510(k) clearances, De Novo requests, or PMA submissions, particularly those with aspirations for both US and global market entry. Projects
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), De Novo, PMA
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
