FDA Regulatory Consultants in Maryland

Compare 2 vetted fda regulatory consultants headquartered in Maryland. Every provider is independently evaluated across 120+ data points for healthcare expertise, compliance, and track record.

2 Providers in Maryland
25 Nationwide
Smith Associates logo

Smith Associates

FDA regulatory consulting for medical device manufacturers since 1994

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Best For

Medical device manufacturers seeking FDA 510(k) clearance, particularly those requiring hand-delivered submissions and rapid response capabilities during interactive FDA reviews. Well-suited for both emerging companies bringing their first device to market and established manufacturers expanding product portfolios across multiple device classifications.

Location:

Crofton, Maryland, United States

Founded:

1994

Team:

1-10

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AltaQ logo

AltaQ

Regulatory, quality, and clinical compliance for life sciences companies

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Best For

AltaQ is best suited for IVD/LDT companies, medical device manufacturers, and pharmaceutical organizations requiring specialized regulatory and quality compliance support for FDA submissions and international market access. The firm serves both established companies navigating complex regulatory pathways and organizations seeking to implement or optimize quality management systems aligned with CLIA/CAP, FDA QMSR, or ISO 13485 standards.

Location:

Bethesda, Maryland, United States

Team:

1-10

Certs:

3 verified

iso 13485 clia cap
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FDA Regulatory Consultants in Other States

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Oregon 2 New Jersey 1 California 1 District of Columbia 1 North Carolina 1
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Frequently Asked Questions

How many fda regulatory consultants are in Maryland?

Curatrix currently lists 2 vetted fda regulatory consultants headquartered in Maryland. There are 25 total fda regulatory consultants listed nationally across all states.

How does Curatrix evaluate fda regulatory consulting providers in Maryland?

Every provider on Curatrix — regardless of location — passes the same rigorous two-stage evaluation. First, they must meet 7 eligibility requirements including US healthcare market presence and verifiable healthcare clients. Then, qualifying providers are scored across 120+ data points covering healthcare experience, compliance certifications, client portfolio, and specialization depth. Location does not influence scoring — a provider in Maryland is evaluated identically to one in any other state.

What certifications do fda regulatory consultants in Maryland typically hold?

Among Maryland-based fda regulatory consultants on Curatrix, the most common certifications include iso 13485, clia, cap. iso 13485 is held by 50% of providers in this region. The right certifications depend on your organization's specific compliance and regulatory requirements.

Should I only consider fda regulatory consulting providers in Maryland?

Not necessarily. While having a local provider in Maryland can be advantageous for on-site work, many fda regulatory consulting services are delivered remotely. Curatrix lists 25 vetted fda regulatory consultants nationally. We recommend evaluating providers based on healthcare expertise, certifications, and fit — not just location. Browse all fda regulatory consultants to see the full national directory.

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