Biologics Consulting
Biologics Consulting – Expert FDA 510(k) & Regulatory Consulting
Biologics Consulting is a specialized FDA regulatory consulting firm dedicated to supporting medical device companies. With 15 years of experience, they offer expert guidance through the complex regulatory landscape, focusing on submissions, product development, and regulatory affairs.
About
Biologics Consulting is a specialized FDA regulatory consulting firm dedicated to supporting medical device companies. With 15 years of experience, they offer expert guidance through the complex regulatory landscape, focusing on submissions, product development, and regulatory affairs.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Biologics Consulting
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 45
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This analysis is based on limited information. Biologics Consulting aims to help clients achieve FDA success, but without more data, a detailed assessment is impossible.
- **Unique value:** Lacking specific details, their differentiation is unclear beyond aiming for FDA success.
- **Ideal projects:** Without more information, it is difficult to define the ideal project. It would likely involve navigating the FDA regulatory process.
- **Confidence score:** 20/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, investigational_device_exemption, pre-submission
- **Device panels:** general_surgery
- **Regulatory pathways:** 510k, pma, de_novo, pre-submission, breakthrough_devices
- **Type:** independent
- **Company:** Biologics Consulting
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 45
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This analysis is based on limited information. Biologics Consulting aims to help clients achieve FDA success, but without more data, a detailed assessment is impossible.
- **Unique value:** Lacking specific details, their differentiation is unclear beyond aiming for FDA success.
- **Ideal projects:** Without more information, it is difficult to define the ideal project. It would likely involve navigating the FDA regulatory process.
- **Confidence score:** 20/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, investigational_device_exemption, pre-submission
- **Device panels:** general_surgery
- **Regulatory pathways:** 510k, pma, de_novo, pre-submission, breakthrough_devices
Key Highlights
- This analysis is based on limited information. Biologics Consulting aims to help clients achieve FDA success, but without more data, a detailed assessment is impossible.
- Lacking specific details, their differentiation is unclear beyond aiming for FDA success.
Certifications & Trust Signals
- 15 years experience
- 45 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Without more information, it is difficult to define the ideal project. It would likely involve navigating the FDA regulatory process.
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
15
Num510k Submitted:
45
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general_surgery
Accepting New Clients:
Yes
