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Biologics Consulting Group

Principal Consultant

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 a...

Experience: 15+ years

Submissions: 45 510(k), 10 De Novo, 5 PMA

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

CardiovascularNeurologyRadiologyOrthopedicDental

Regions Served

Biologics Consulting Group provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-PacificLatin AmericaMiddle East & Africa

Credentials & Recognition

Certifications

RAC-US Certification
US FDA
2015
CQE Certification
American Society for Quality
2018

Professional Experience

Former FDA Regulatory Specialist
Verified FDA experience
Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

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...

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

CardiovascularNeurologyRadiologyOrthopedicDental

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Former roles: Former FDA regulatory specialist.
  • Regions: US, EU, CA, APAC, LATAM, MEA
  • Background: 15+ years of regulatory experience.

Cruxi view

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.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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