Biologics Consulting Group
Expert FDA Regulatory Guidance for Medtech - 510k, De Novo, PMA & More
Biologics Consulting Group, led by Principal Consultant Donna-Bea Tillman, offers unparalleled FDA regulatory guidance for medtech companies. With a former director of the CDRH Office of Device Evaluation at its helm and 15 years of dedicated experience, the firm has a proven track record of success, including 45 510(k) and 10 De Novo submissions. They provide comprehensive services from pathway assessment and submission authoring to post-market support, delivering tailored and efficient regulatory solutions. Biologics Consulting Group is committed to timely and efficient regulatory approvals, making them an essential partner for navigating the intricate medtech regulatory landscape.
About
Biologics Consulting Group, led by Principal Consultant Donna-Bea Tillman, offers unparalleled FDA regulatory guidance for medtech companies. With a former director of the CDRH Office of Device Evaluation at its helm and 15 years of dedicated experience, the firm has a proven track record of success, including 45 510(k) and 10 De Novo submissions. They provide comprehensive services from pathway assessment and submission authoring to post-market support, delivering tailored and efficient regulatory solutions. Biologics Consulting Group is committed to timely and efficient regulatory approvals, making them an essential partner for navigating the intricate medtech regulatory landscape.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Biologics Consulting Group
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 45
- **Ex-FDA:** Yes
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC, LATAM, MEA
- **Client types:** startup, sme, large_medtech, academic
- **Location:** United States (Ohio)
- **Availability:** available_now
- **Certifications:** RAC-US Certification, CQE Certification
### **Cruxi analysis**
- **Strength summary:** Biologics Consulting Group emerges as a distinguished regulatory consultancy for the medtech industry, boasting a team with profound expertise and an impressive history of success. Anchored by a Principal Consultant who is a former Director of the FDA's CDRH Office of Device Evaluation, the firm provides exceptional guidance through intricate FDA pathways such as 510(k), De Novo, and PMA. With 15 years dedicated to medical device regulations, they have achieved significant milestones, successfully managing 45 510(k) and 10 De Novo submissions. Their comprehensive service suite, encompassing pathway assessments, submission authoring, and post-market support, coupled with their ability to deliver efficient, customized regulatory solutions, solidifies their role as an indispensable partner for medtech professionals navigating complex regulatory terrains.
- **Unique value:** The firm's unique value proposition is rooted in its direct, former FDA leadership experience, offering an insider's perspective on regulatory expectations and a proven history of success across numerous critical submissions, establishing them as a highly trusted and exceptionally effective partner for driving medtech innovation.
- **Ideal projects:** Biologics Consulting Group is the ideal partner for medtech companies of all sizes, from burgeoning startups to established SMEs and large enterprises, seeking expert navigation of FDA regulatory pathways. They excel in projects involving 510(k), De Novo, and PMA submissions, demonstrating particular strength in cardiovascular, orthopedic, neurology, radiology, and IVD devices, including SaMD. Companies undertaking their initial submission, grappling with complex device classifications, or requiring comprehensive support for clinical trials, QMS implementation, or post-market surveillance will derive substantial benefit. Early engagement with Biologics Consulting Group is highly recommended for strategic planning and to ensure efficient, timely access to market.
- **Confidence score:** 100/100
- **Last analyzed:** Sat Dec 20 2025 01:42:03 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** cardiovascular, orthopedic, neurology, radiology, ivd, dental, ophthalmic, general-hospital, anesthesiology, clinical-chemistry, hematology, pathology, software-samd, other
- **Device panels:** cardiovascular, neurology, radiology, orthopedic, dental, ivd, wearable_digital, other
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, post_market
- **Type:** firm
- **Company:** Biologics Consulting Group
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 45
- **Ex-FDA:** Yes
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC, LATAM, MEA
- **Client types:** startup, sme, large_medtech, academic
- **Location:** United States (Ohio)
- **Availability:** available_now
- **Certifications:** RAC-US Certification, CQE Certification
### **Cruxi analysis**
- **Strength summary:** Biologics Consulting Group emerges as a distinguished regulatory consultancy for the medtech industry, boasting a team with profound expertise and an impressive history of success. Anchored by a Principal Consultant who is a former Director of the FDA's CDRH Office of Device Evaluation, the firm provides exceptional guidance through intricate FDA pathways such as 510(k), De Novo, and PMA. With 15 years dedicated to medical device regulations, they have achieved significant milestones, successfully managing 45 510(k) and 10 De Novo submissions. Their comprehensive service suite, encompassing pathway assessments, submission authoring, and post-market support, coupled with their ability to deliver efficient, customized regulatory solutions, solidifies their role as an indispensable partner for medtech professionals navigating complex regulatory terrains.
- **Unique value:** The firm's unique value proposition is rooted in its direct, former FDA leadership experience, offering an insider's perspective on regulatory expectations and a proven history of success across numerous critical submissions, establishing them as a highly trusted and exceptionally effective partner for driving medtech innovation.
- **Ideal projects:** Biologics Consulting Group is the ideal partner for medtech companies of all sizes, from burgeoning startups to established SMEs and large enterprises, seeking expert navigation of FDA regulatory pathways. They excel in projects involving 510(k), De Novo, and PMA submissions, demonstrating particular strength in cardiovascular, orthopedic, neurology, radiology, and IVD devices, including SaMD. Companies undertaking their initial submission, grappling with complex device classifications, or requiring comprehensive support for clinical trials, QMS implementation, or post-market surveillance will derive substantial benefit. Early engagement with Biologics Consulting Group is highly recommended for strategic planning and to ensure efficient, timely access to market.
- **Confidence score:** 100/100
- **Last analyzed:** Sat Dec 20 2025 01:42:03 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** cardiovascular, orthopedic, neurology, radiology, ivd, dental, ophthalmic, general-hospital, anesthesiology, clinical-chemistry, hematology, pathology, software-samd, other
- **Device panels:** cardiovascular, neurology, radiology, orthopedic, dental, ivd, wearable_digital, other
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, post_market
Key Highlights
- Biologics Consulting Group emerges as a distinguished regulatory consultancy for the medtech industry, boasting a team with profound expertise and an impressive history of success. Anchored by a Principal Consultant who is a former Director of the FDA's CDRH Office of Device Evaluation, the firm provides exceptional guidance through intricate FDA pathways such as 510(k), De Novo, and PMA. With 15 years dedicated to medical device regulations, they have achieved significant milestones, successful
- The firm's unique value proposition is rooted in its direct, former FDA leadership experience, offering an insider's perspective on regulatory expectations and a proven history of success across numerous critical submissions, establishing them as a highly trusted and exceptionally effective partner for driving medtech innovation.
Certifications & Trust Signals
- 15 years experience
- 45 510(k)s submitted (self-reported)
- Ex-FDA
Buyer Snapshot
Best for
- Biologics Consulting Group is the ideal partner for medtech companies of all sizes, from burgeoning startups to established SMEs and large enterprises, seeking expert navigation of FDA regulatory pathways. They excel in projects involving 510(k), De Novo, and PMA submissions, demonstrating particular strength in cardiovascular, orthopedic, neurology, radiology, and IVD devices, including SaMD. Com
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:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
15
Num510k Submitted:
45
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, neurology, radiology, orthopedic, dental, ivd, wearable_digital, other
Technology Types:
samd, ai_ml, mobile_app, cloud_platform, wearable_patch, implantable, ivd_test, combo_product
Engagement Models:
fixed_fee
Accepting New Clients:
Yes
