What services does Biologics Consulting offer?

Biologics Consulting offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Biologics Consulting specialize in?

Biologics Consulting specializes in 510k, Pma, De Novo and other FDA regulatory pathways for medical devices.

What is Biologics Consulting's regulatory experience?

Biologics Consulting has 15+ years of experience, 45+ 510(k) submissions in FDA regulatory affairs.

Biologics 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.

Experience: 15+ years

Submissions: 45 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaDe NovoPre-SubmissionBreakthrough Devices

Device Specialties

General Surgery

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kPmaDe NovoPre-SubmissionBreakthrough Devices

Device Specialties

General Surgery

Services Offered

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

Background: 15+ years of regulatory experience.

Cruxi view

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.

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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