Regulatory Support for Drug Registration in USA

The pharmaceutical market in the United States of America (USA) is one of the most structured and closely regulated markets in the world. The U.S. Food and Drug Administration (FDA) governs the manufacture, import, distribution, and marketing of pharmaceutical products under the Federal Food, Drug, and Cosmetic (FD&C) Act and related regulations. Each product type, whether a prescription drug, generic, OTC, or biologic requires a distinct regulatory pathway for market authorization. DDReg provides US FDA Drug Registration Services, supporting end-to-end pharmaceutical product registration in the USA.

Pharmaceutical products must be registered with the FDA through one of several submission routes, depending on their classification and composition:

• New Drug Application (NDA): For an Investigational New Drug (IND) transitioning to marketing authorization.
• Abbreviated New Drug Application (ANDA): For generic drugs demonstrating bioequivalence to a reference listed drug.
• Biologics License Application (BLA): For biologic products such as vaccines, monoclonal antibodies, and therapeutic proteins.

• Stand-alone NDA (505(b)(1)): For new, innovative drug products supported by complete preclinical and clinical data.
• 505(b)(2) Application: For modified versions of approved drugs (new dosage forms, combinations, or indications) using existing data in part.
• ANDA (505(j)): For generics with identical active ingredients, strength, dosage form, and route of administration.
• Petitioned ANDA (505(j)): For generics requiring minor formulation or labeling differences approved via citizen petition.

The U.S. FDA operates an electronic system for Drug Establishment Registration and Drug Listing under 21 CFR Part 207, which ensures transparency in manufacturing and supply chain operations.

• Establishment registration enables FDA oversight of the manufacturing, repacking, or relabeling sites — both domestic and foreign — ensuring they meet U.S. standards for safety and supply-chain control.
• Drug product listing identifies each product in the U.S. supply chain and supports FDA’s ability to monitor product status, conduct recalls, manage shortages, and enforce compliance.
• Even if your product falls under an OTC monograph or is a generic, registration and listing obligations remain vital. Non-compliance may lead to import restriction, enforcement action, or delayed market entry.
• Aligning with these regulatory obligations early enhances your brand’s commercial agility — reducing review cycles, protecting supply-chain integrity, and supporting sustainable U.S. operations.

• + Regulatory Strategy & Market Entry Planning
  • Determine whether your pharmaceutical product falls under NDA, ANDA, OTC monograph, or repack/remanufacture category.
  • Map out pharma product registration, listing, submission, and label-control requirements.
  • Develop a timeline-aligned regulatory roadmap that supports your U.S. launch and supply-chain strategy.
• + U.S. Agent Management & Drug Establishment Registration Services
  • Complete FDA drug establishment registration (21 CFR Part 207) for domestic and international sites.
  • Coordinate U.S. Agent appointment for foreign operations and ensure all FDA communications channels are established.
  • Manage annual renewals, updates, and data accuracy to maintain your registration status.
• + FDA Drug Product Listing & Electronic Submission Services
  • Prepare and submit drug-product listings via FDA’s eDRLS (Electronic Drug Registration and Listing System).
  • Ensure compliance with SPL format, NDCs, monograph identifiers, and relevant submission fields.
  • Support OTC-monograph listing or generics as required.
• + Post-Registration Compliance & Lifecycle Readiness
  • Monitor FDA’s changing listing requirements, monograph reforms, and regulatory enforcement trends.
  • Set up review systems for product changes, repackaging, recalls, and supply-chain shifts.
  • Advise on regulatory best practices to maintain audit readiness and minimize risk over the product lifecycle.

Our regulatory specialists understand not only the scientific and procedural rigor of U.S. drug regulation but also the commercial realities that shape successful submissions. From strategic pathway selection to meticulous data preparation and lifecycle compliance, DDReg ensures your regulatory framework is both compliant and competitive. With a proven record of supporting international manufacturers and emerging pharmaceutical innovators, we deliver regulatory affairs solutions that integrate speed, precision, and long-term sustainability.