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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.
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