We bridge the gap between customs expertise and FDA requirements — keeping your pharmaceutical, food, and medical shipments compliant, cleared, and moving.
What We Do
End-to-end FDA compliance advisory across pharmaceutical, food, and medical device imports — backed by real clinical expertise.
Prior Notice requirements, import alerts, detention responses, and FDA shipment release strategies for pharmaceutical and medical products entering the US.
Serialization, tracing, and verification requirements for pharmaceutical importers and distributors under the Drug Supply Chain Security Act.
Expert review of temperature excursion reports and stability data for biologics, vaccines, and specialty drug shipments.
Review of pharmaceutical, food, and medical device labeling for FDA 21 CFR compliance prior to import or US distribution.
On-call PharmD expertise for customs brokers handling pharmaceutical, food, biologic, and medical device shipments requiring FDA review.
FDA Prior Notice for food shipments, facility registration requirements, food labeling compliance, and detention release strategies for imported food products.
Common Pain Points
These are the situations our clients face before they find us. If any of these resonate, we should talk.
Shipment held at port with no FDA explanation or response strategy in place.
FDA detention letter received with no pharmacist to interpret or respond to it.
Cold chain temperature excursion with no documentation or stability support.
Customs broker with no expert resource to answer FDA drug or food compliance questions.
Pharmaceutical labeling flagged by FDA with no regulatory review process in place.
Controlled substance shipment delayed due to missing or incomplete DEA documentation.
Who We Work With
We work with businesses across the import and healthcare supply chain that need PharmD-level FDA compliance expertise.
Licensed Customs Brokers
Pharmaceutical Importers & Distributors
Specialty Pharmacies
Medical Device Companies
Biotech & Biologics Importers
Hospital Supply Chain Teams
Nutraceutical, Supplement & Food Importers
Foreign Pharma Entering US Market
Our Advantage
The combination of credentials and partnerships we bring to the table is genuinely uncommon in this space.
Expertise most regulatory consultants simply don't have — we understand the drugs, biologics, and food products we advise on at a clinical and molecular level.
Direct partnership with a licensed US customs broker gives clients a fully integrated solution — customs clearance and FDA compliance under one roof.
Deep working knowledge of 21 CFR, DSCSA, FDA import alert processes, Prior Notice requirements, and cold chain compliance standards across product types.
You reach a PharmD directly — not a junior associate. Fast turnaround on time-sensitive shipment issues, detention letters, and urgent compliance questions.
We serve pharmaceutical, food, and medical device clients — bringing cross-industry regulatory perspective that single-sector consultants can't offer.
Rooted in one of the country's largest import and logistics hubs, with the capability to serve clients across the US remotely and on-site.
Engagement Options
Flexible engagement models to match your needs — whether you need ongoing support or help with a single shipment.
For Ongoing Needs
per month
Monthly on-call compliance support for customs brokers and importers with ongoing FDA shipment needs. Priority response included.
Get StartedMost Popular
starting price per project
Flat fee consulting for specific shipments, documentation reviews, detention responses, or FDA response strategies. Scope defined upfront.
Get StartedFor Urgent Situations
per hour
Flexible hourly consulting for urgent FDA questions, shipment holds, or time-sensitive compliance reviews. Available on short notice.
Get StartedGet In Touch
We offer a complimentary 20-minute consultation to discuss your FDA compliance challenge. Fill out the form and we'll be in touch within one business day.
Request a Free Consultation
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