FDA Regulatory and Compliance Consulting

We support MedTech & Pharma clients with regulatory consulting, compliance strategies, and full QA/QMS support.

What is the role of the FDA in marketing your medical device?

The FDA ensures medical device safety and efficacy. Our experts help interpret requirements, submit clearance documents, and strategize for a US launch.

How can we help you release your medical device to the market under the FDA’s regulations?

We’ll map the right regulatory path, support technical files, and provide full lifecycle support—from GAP analysis to launch.

How can you benefit from our consulting services?

📜

Lower regulatory risk

Clear documents for every regulatory step.

⏱️

Lean time to market

Accelerated product realization in all phases.

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Result-focused strategy

Competence and dedication for every client.

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Regulatory vigilance

Global reach and compliance oversight.

Find out if your product is a medical device under FDA regulations

Unsure how your product is regulated by the FDA? Let our experts clarify with a rapid risk and classification assessment—before you invest.

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Our process

Initiation: Initial call, project scoping, and regulatory requirements review.
Process documentation: Gap analysis, validation plan, and standard operating procedures.
Submission: Draft FDA correspondence and complete application files for you.
Post-approval phase: Training/consulting and QMS strategy for ongoing compliance.

10+
years experience

200+
medical products

50+
global markets

"Working for the MedTech sector allows me to continuously challenge myself."

— Dr. Erika Klein, Compliance Lead