FDAMap
Brij Strategic Consultations, LLC
Expert Regulatory Services for Drugs, Biologics, and Devices
FDAMap provides expert regulatory services across drugs, biologics, and devices, offering comprehensive support for navigating the complex FDA landscape. With a decade of experience, they specialize in strategic regulatory planning, risk management, and quality system implementation, ensuring compliance and facilitating market access for a wide range of medical products.
About
FDAMap provides expert regulatory services across drugs, biologics, and devices, offering comprehensive support for navigating the complex FDA landscape. With a decade of experience, they specialize in strategic regulatory planning, risk management, and quality system implementation, ensuring compliance and facilitating market access for a wide range of medical products.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** FDAMap
- **Years of experience:** 10
- **510(k)s submitted (self-reported):** 35
- **Regions served:** US
- **Client types:** sme
- **Location:** United States
- **Availability:** available_now
- **Certifications:** rac-us
### **Cruxi analysis**
- **Strength summary:** Experience with De Novo submissions for novel devices. Global regulatory expertise across multiple markets. Regulatory services across drugs, biologics, and devices
- **Unique value:** Regulatory services across drugs, biologics, and devices
- **Ideal projects:** Best suited for startup to enterprise projects. Specializes in General devices
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, de_novo, investigational_device_exemption, annual_reports
- **Device classes:** class-ii, class-i, class-iii
- **Specialties:** regulatory strategy, risk management, usability engineering, clinical evaluation, preclinical testing, clinical trials, quality system implementation, cardiovascular, radiology, ophthalmic, clinical-chemistry, software-samd, other, hematology, general-hospital, ivd, orthopedic, neurology, dental, anesthesiology, pathology
- **Device panels:** general_surgery, gastroenterology, urology, cardiovascular, orthopedic, neurology, other
- **Regulatory pathways:** 510k, de_novo, pma, pre-submission, breakthrough_devices, humanitarian_device_exemption
- **Type:** firm
- **Company:** FDAMap
- **Years of experience:** 10
- **510(k)s submitted (self-reported):** 35
- **Regions served:** US
- **Client types:** sme
- **Location:** United States
- **Availability:** available_now
- **Certifications:** rac-us
### **Cruxi analysis**
- **Strength summary:** Experience with De Novo submissions for novel devices. Global regulatory expertise across multiple markets. Regulatory services across drugs, biologics, and devices
- **Unique value:** Regulatory services across drugs, biologics, and devices
- **Ideal projects:** Best suited for startup to enterprise projects. Specializes in General devices
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, de_novo, investigational_device_exemption, annual_reports
- **Device classes:** class-ii, class-i, class-iii
- **Specialties:** regulatory strategy, risk management, usability engineering, clinical evaluation, preclinical testing, clinical trials, quality system implementation, cardiovascular, radiology, ophthalmic, clinical-chemistry, software-samd, other, hematology, general-hospital, ivd, orthopedic, neurology, dental, anesthesiology, pathology
- **Device panels:** general_surgery, gastroenterology, urology, cardiovascular, orthopedic, neurology, other
- **Regulatory pathways:** 510k, de_novo, pma, pre-submission, breakthrough_devices, humanitarian_device_exemption
Key Highlights
- Experience with De Novo submissions for novel devices. Global regulatory expertise across multiple markets. Regulatory services across drugs, biologics, and devices
- Regulatory services across drugs, biologics, and devices
Certifications & Trust Signals
- 10 years experience
- 35 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Best suited for startup to enterprise projects. Specializes in General devices
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, SaMD
Years Experience:
20
Num510k Submitted:
35
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general_surgery, gastroenterology, urology, cardiovascular, orthopedic, neurology, other
Technology Types:
samd, ai_ml, mobile_app
Accepting New Clients:
Yes
Supports Estar:
No
Supports Rta Remediation:
No
Supports Predicate Research:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Consulting
