Comprehensive Regulatory Consulting Services

624Advisors provides tailored consulting services to help businesses successfully navigate the product development and regulatory approval process. Our expertise supports every phase, from establishing clinical utility support to securing reimbursement, ensuring a seamless journey to market.

New Project

Our Range of Services

Regulatory/Clinical/Compliance

Strategy Development

Aligning regulatory and business strategies.

IVD, CDx, Biomarkers,

and Diagnostics

Specialty multi endpoint validation models and compliance.

Value Added SME Short

Term Support

Medical Writing, Regulatory Tactical Services, Remediation, and Regulatory Submissions.

Risk Based Value

Proposition Development

Building the milestone-based cost effective product development and regulatory Value Proposition.

Business-Centric Product Life Cycle Management

1

Concept

1

2

Prototype

2

3

Preclinical Design Development and Validation

3

4

Human Factors Engineering and Usability

4

5

Clinical Trial Design and Implementation

5

6

Manufacturing Considerations

6

7

Approval Submission

7

8

Reimbursement Studies and Approvals

8

9

Marketing

9

10

Commercial Use & Post-Marketing Studies

10

11

Prevent Obsolescence: upgrades and
expanded indications

11

Connect With Us

We’re here to guide you through each step with strategies that align your goals with regulatory requirements, setting your product up for lasting success. Contact us for clinical utility development, and more.

Let’s Talk