COMPREHENSIVE REGULATORY SERVICES
Enabling Market Entry & Growth for Pharma and Nutrition Innovators
US FDA Food Facility Registration
- Who Needs It: Manufacturers, processors, packers, or holders of food, dietary supplements, and nutritional ingredients for human or animal consumption in the U.S.
- Why: Required under the U.S. Food Safety Modernization Act (FSMA).
- Timeline: Typically completed within 2–5 business days if all information is ready.
DUNS Registration
- Who Needs It: All facilities engaging with FDA submissions and business operations.
- Why: Required to obtain a D-U-N-S® Number, used for facility validation and submissions.
- Timeline: 1–5 business days via Dun & Bradstreet.
Prior Notice System Interface (PNSI)
- Who Needs It: Anyone importing food, dietary supplements, or related ingredients into the U.S.
- Why: Required to notify FDA of incoming shipments prior to arrival to ensure safety and traceability.
- Timeline: Real-time online filing; must be submitted before shipment reaches U.S. borders.
US FDA Facility Registration & FEI Assignment
- Who Needs It: Facilities involved in manufacturing, repackaging, relabeling, or holding drug, supplement, or food products for U.S. distribution need FDA registration.
- Why: Mandatory for legal operation in the U.S.; FEI (Facility Establishment Identifier) is assigned during registration.
- Timeline: Typically 3–7 business days.
National Drug Code (NDC) or Labeler Code Request & Assignment
- Who Needs It: Companies intending to market APIs and finished drugs under their label in the U.S. require national drug code registration to ensure pharmaceutical regulatory compliance.
- Why: Required for product tracking, identification, and marketing compliance.
- Timeline: Labeler code approval in 7–10 business days; NDC assignment in 2–5 days after.
Drug Listing and Certification
- Who Needs It: Companies with FDA-registered facilities and approved NDCs.
- Why: Mandatory to list drug products with the FDA for pharmaceutical regulatory compliance in the US market.
- Timeline: 2–7 business days, depending on readiness.
IOR (Importer of Record) Setup & Maintenance
- Who Needs It: Foreign companies exporting products (APIs, supplements, excipients, or drugs) to the U.S.
- Why: Required for customs clearance and FDA compliance during import.
- Timeline: Setup takes 1–2 weeks with complete documentation.
Outsourcing Facility Registration (503B)
- Who Needs It: Facilities compounding sterile medications without individual prescriptions.
- Why: Required to operate legally under FDA's 503B section; allows distribution across states.
- Timeline: 2–4 weeks, depending on readiness and documentation.
Compounded Drug Product Reporting
- Who Needs It: Registered 503B outsourcing facilities and certain 503A compounders.
- Why: Biannual FDA reporting is mandatory for transparency and safety tracking.
- Timeline: Reporting periods are in January and July; submissions take 2–3 business days if data is prepared.
DSCSA Annual Reporting (Drug Distributors & 3PLs)
- Who Needs It: Wholesale drug distributors and third-party logistics providers.
- Why: Required under the Drug Supply Chain Security Act to maintain transparency in the distribution chain.
- Timeline: Annual; takes 1–2 weeks for preparation and submission.
Generic Drug Self-Identification (GDUFA)
- Who Needs It: API and FDF manufacturers for generic drugs.
- Why: Required for generic drug applications and GDUFA fee assessments.
- Timeline: 3–5 business days if information is ready.
Cosmetic Facility Registration & Product Listing (MoCRA Compliance)
- Who Needs It: Companies manufacturing or marketing cosmetic products in the U.S.
- Why: Increasingly expected under the Modernization of Cosmetics Regulation Act (MoCRA).
- Timeline: 5–10 business days, depending on data accuracy.
CDER Export Certification (CDER eCATS)
- Who Needs It: Drug manufacturers/exporters seeking to verify product status for international markets.
- Why: Provides official certification that products meet FDA approval or pharmaceutical regulatory compliance standards.
- Timeline: 2–3 weeks, varies by product and destination country.
CVM Export Certification (CVM eCATS)
- Who Needs It: Veterinary drug manufacturers/exporters needing proof of compliance for global sales.
- Why: Verifies regulatory status for products under the FDA’s Center for Veterinary Medicine.
- Timeline: 2–3 weeks, depending on complexity and country requirements.
ZUVCHEM offers expert regulatory support to help you confidently navigate U.S. market entry. From evaluating technical documentation to identifying compliance risks, we ensure your products meet FDA expectations, streamlining approval and accelerating your path to market.