Regulatory Consulting
Serialization, labeling, and import/export compliance for FDA and international markets.
Moving drug across borders means satisfying a different rulebook in every market — serialization mandates, label content, customs and import licenses. Bensen Solutions keeps product compliant so shipments clear rather than sit.
We support serialization (including DSCSA), multi-country labeling, and the documentation behind FDA submissions and international distribution.
What this engagement includes
Serialization (DSCSA)
Serialization and traceability strategy to meet the U.S. Drug Supply Chain Security Act and global equivalents.
Labeling compliance
Label content, translations, and booklet labels that satisfy each market's regulatory requirements.
Import / export & customs
Import licenses, customs documentation, and country-entry requirements coordinated for clean clearance.
FDA submission support
Supply chain documentation and CMC-adjacent support for regulatory submissions.
International market compliance
Country-by-country requirements mapped so distribution stays compliant across regions.
Regulatory intelligence
Monitoring of changing serialization and import rules so plans stay ahead of new mandates.
How we work
- 1
Map the requirements
We identify the serialization, labeling, and import rules for every market in scope.
- 2
Build the compliance plan
We define the documentation, labels, and processes needed to meet them.
- 3
Execute & document
We coordinate serialization, labeling, and customs so shipments clear cleanly.
- 4
Monitor for change
We track evolving mandates and update the plan before they take effect.
What you can expect
- Shipments that clear customs without delay
- Labels compliant in every destination market
- Serialization aligned to DSCSA and global rules
- No surprises from changing regulations
Frequently asked questions
- What is DSCSA and who does it affect?
- The Drug Supply Chain Security Act (DSCSA) is U.S. legislation requiring an interoperable, electronic system to trace prescription drugs through the supply chain. It affects manufacturers, repackagers, wholesale distributors, and dispensers, mandating product serialization, verification, and transaction records.
- Why is drug labeling so complex for international trials?
- Each country sets its own requirements for label content, language, and format, and multi-country studies often need booklet labels covering many markets in one kit. Getting content, translations, and regulatory elements right for every destination is what keeps shipments compliant and importable.
- Do you support both clinical and commercial regulatory needs?
- Yes. We support serialization, labeling, and import/export compliance for investigational product in clinical trials as well as commercial distribution, including the documentation that connects supply chain activities to FDA and international submissions.