Biologics Consulting Group
Biologics Consulting Group, Inc.
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.
Buyer Snapshot
Best for
- Companies seeking FDA regulatory guidance for medical devices, drugs, biologics, and combination products.
- Organizations needing assistance with regulatory submission preparation and strategy.
How engagement typically works
- Consultative approach to regulatory pathway solutions.
- Expert support for FDA meetings and submissions.
Typical deliverables
- Tailored regulatory pathway strategies.
- Assistance with Quality System documentation.
- Preparation of regulatory submissions.
- Meeting preparation and due diligence assessments.
Good to know
- Best when requiring specialized FDA regulatory expertise for complex product types.
HQ:
Alexandria, United States
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, De Novo 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, Combination product
Supports Rta Remediation:
No
Supports Predicate Research:
No
Years Experience:
30
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
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
