DRUG
Streamline your path to the U.S. market with expert FDA representation for the pharmaceutical industry. We handle everything from establishment registration and drug listings to labeling compliance and inspection prep, ensuring your OTC or prescription drugs meet all regulatory hurdles for long-term success.
Comprehensive FDA Compliance for Pharma Companies
Expert U.S. Agent Services for Domestic & Foreign OTC & Prescription Drug Manufacturers. Navigate the complex FDA regulatory landscape with confidence.
FDA Facility Registration & Drug Listing
We streamline the mandatory registration of your manufacturing facilities and accurate listing of all your OTC and prescription drug products with the FDA.
Register Your FacilityU.S. Agent Representation
Acting as the crucial communication link between foreign companies and the FDA, handling inquiries, and facilitating critical correspondence.
Appoint Your U.S. AgentLabeling & Advertising Review
Ensure your drug labels, inserts, and promotional materials meet stringent FDA regulations for accuracy, safety, and claims substantiation.
Review My LabelscGMP Consulting (21 CFR Part 211)
Establishing and maintaining robust quality systems to ensure your drug products consistently meet FDA manufacturing expectations.
Optimize cGMP NowPre-Approval & Inspection Readiness
Prepare your facility for successful FDA inspections (PAI or routine) through mock audits and comprehensive technical training.
Prepare for InspectionAdverse Event Reporting
Establish efficient systems for monitoring and reporting ADEs to the FDA, fulfilling your pharmacovigilance responsibilities.
Report an ADEImport & Export Support
Navigate the complexities of drug logistics and supply chain security to avoid costly entry delays or product rejections.
Ensure Smooth ImportsAnnual Reporting & Renewal Management
Timely submission of annual establishment renewals, product updates, and compliance certifications.
Stay Compliant Year-Round483 & Warning Letter Remediation
Expert assistance in crafting timely responses to FDA observations and implementing robust corrective action (CAPA) plans.
Respond to FDA ActionCustomized Compliance Training
Tailored training programs on cGMP principles, data integrity, and compliance best practices for your entire organization.
Train Your TeamPrescription Drug Compliance
Navigate the rigorous pathway of CDER regulations with precision. We provide full U.S. Agent representation for foreign manufacturers, managing Establishment Registrations, NDC Drug Listings, and GDUFA/PDUFA requirements. Our team ensures your sterile or non-sterile manufacturing processes meet strict cGMP 21 CFR Part 211 standards for the U.S. market.
Secure Rx ComplianceOTC Drug Monograph Support
Bringing Over-the-Counter (OTC) products to the U.S. requires strict adherence to Drug Facts labeling and Monograph compliance. From facility registration to "Active Ingredient" verification, we help you launch analgesics, sunscreens, and other OTC products smoothly while maintaining audit-ready quality systems.
Launch OTC ProductOTC Cosmetic & MoCRA Compliance
When a cosmetic makes a drug claim (like SPF or anti-acne), it must meet both cosmetic and drug regulations. We navigate the complexities of MoCRA and OTC drug requirements, ensuring your formulations, facility registrations, and safety substantiation meet the latest FDA mandates.
Ensure Cosmetic SafetyFDA Compliance FAQ for Drug Companies
Expert U.S. Agent support for prescription drug, OTC drug, and OTC cosmetic manufacturers — domestic and international.
Frequently Asked Questions
1. What is a U.S. Agent for FDA purposes?
A U.S. Agent represents foreign precription, OTC drug, active pharmaceutical ingredient (API), and OTC cosmetic manufacturers before the FDA and serves as the official communication liaison.
2. Do foreign OTC drug companies need a U.S. Agent?
Yes. Foreign OTC drug manufacturers must designate a U.S. Agent when registering facilities and listing products with FDA.
3. Is a U.S. Agent required for prescription drug manufacturers?
Foreign prescription drug manufacturers must appoint a U.S. Agent for FDA registration and communications.
4. Do cosmetic companies need FDA registration?
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), manufacturers must register their establishments with the FDA and renew their registration every two years. They must also list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
5. What is FDA drug establishment registration?
It is the mandatory annual registration of drug manufacturing facilities with the FDA. Establishment owners and operators (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs, (including human drugs, veterinary drugs, and biological drug products) must register their establishments and submit listing information for all drugs in commercial distribution.
6. What is drug listing?
Drug listing requires submitting product details, labeling, and NDC information to FDA.
7. What are cGMP requirements?
Current Good Manufacturing Practices ensure drugs are consistently produced and controlled to quality standards.
8. What happens during an FDA inspection?
FDA reviews manufacturing processes, documentation, quality systems, and regulatory compliance.
9. What is an FDA Warning Letter?
A Warning Letter is issued when FDA identifies significant regulatory violations.
10. Can a U.S. Agent respond to FDA inquiries?
Yes. A U.S. Agent can coordinate and assist with regulatory communications and submissions.
11. What is MoCRA?
The Modernization of Cosmetics Regulation Act expands FDA oversight of cosmetic products.
12. Are OTC monograph drugs regulated differently?
Yes. OTC drugs must comply with applicable FDA monographs and labeling requirements.
13. How often must drug establishments renew registration?
Drug establishments must renew registration annually between October 1 and December 31.
14. What is an NDC number?
The National Drug Code uniquely identifies drug products marketed in the United States.
15. What FDA services do you provide?
We provide U.S. Agent services, etablishment registration, drug listing, compliance audits, inspection support, and regulatory consulting.
16. Do you support foreign manufacturers?
Yes. We specialize in assisting international manufacturers entering the U.S. market.
17. What are FDA import alerts?
Import alerts allow FDA to detain products entering the U.S. without physical examination.
18. Can you assist with FDA 483 responses?
Yes. We help draft and manage corrective action responses to FDA 483 observations.
19. What is SPL submission?
Structured Product Labeling (SPL) is the electronic format required for FDA drug listing submissions.
20. Do OTC cosmetic-drug hybrids require special compliance?
Yes. Products marketed as both cosmetics and drugs must comply with both regulatory frameworks.
21. How long does FDA registration take?
Electronic submissions are typically processed within days if documentation is complete.
22. Do domestic companies need a U.S. Agent?
No. Domestic companies do not require a U.S. Agent but may use regulatory consulting services.
23. What are adverse event reporting requirements?
Serious adverse events must be reported to FDA within mandated timelines.
24. Can you act as authorized U.S. correspondent?
Yes. We serve as official FDA correspondent for regulatory matters.
25. What industries do you serve?
Prescription drug manufacturers, OTC drug companies, cosmetic brands, and contract manufacturers.
26. Do you offer cGMP audits?
Yes. We perform mock FDA inspections and gap assessments.
27. Can you help with FDA compliance strategy?
We provide customized compliance roadmaps to reduce enforcement risk.
28. What documents are needed for drug listing?
Labeling, ingredient details, NDC data, and manufacturing site information are required.
29. Is annual reporting required for cosmetics?
Under MoCRA, certain cosmetic facilities must maintain updated records and listings.
30. What are FDA labeling requirements?
Labels must include drug facts, warnings, directions, active ingredients, and manufacturer details.
31. How do you support FDA inspections?
We prepare documentation, conduct mock audits, and assist during inspection responses.
32. How can we start FDA compliance services?
Contact us for a compliance assessment and customized onboarding plan.