Which authority regulates medicines and medical devices in the USA?

The U.S. Food and Drug Administration (FDA) regulates drugs, biologics, medical devices, vaccines, and OTC products in the United States.

What FDA applications are required for drug approval in the USA?

Drug approvals require NDA, ANDA, or BLA submissions, depending on whether the product is a new drug, generic, or biologic.

Do foreign manufacturers need FDA approval to market products in the USA?

Yes. Foreign manufacturers must comply with FDA regulations, including establishment registration, product approval, and GMP compliance.

What is the difference between NDA, ANDA, and 505(b)(2) pathways?

NDA is for new drugs, ANDA for generics, and 505(b)(2) allows partial reliance on existing data for faster approval.

Regulatory Services in USA

Regulatory Affairs Services Provider in USA

A well-structured regulatory system is critical to ensure the safety, efficacy, and quality of healthcare products throughout development and post-approval stages.

The United States Food and Drug Administration (FDA) is the primary regulatory authority overseeing pharmaceuticals, biologics, medical devices, vaccines, dietary supplements, cosmetics, and pharmacovigilance consulting activities in the United States.

Within the FDA, the Center for Drug Evaluation and Research (CDER) manages regulatory review for new drugs, generics, and OTC products through pathways such as NDAs and ANDAs. Biologic products are evaluated under BLAs, with additional oversight shared with CBER depending on product classification.

Given the complexity of regulatory requirements and frequent updates in U.S FDA guidance, global manufacturers often face delays and challenges in securing US market authorization.

DDReg Pharma provides end-to-end US FDA regulatory consulting designed to streamline submissions, reduce compliance risks, and support faster product approvals.

Why Choose DDReg for US FDA Regulatory Consulting Services?

DDReg Pharma is a global regulatory consulting partner supporting pharmaceutical and healthcare companies with strategic guidance and execution across the US FDA lifecycle.

We design tailored regulatory approaches aligned with current FDA expectations to support accurate, compliant, and timely submissions.

Our services include complete support for New Drug Applications (NDA), including 505(b)(1) and 505(b)(2) routes, as well as Abbreviated New Drug Applications (ANDA) under 505(j). We assist with the preparation and review of CMC documentation, clinical and non-clinical study reports, protocols, and full eCTD submissions (Modules 1–5).

We also support regulatory correspondence with the FDA, submission readiness checks, deficiency response handling, and ongoing lifecycle activities such as annual reports, supplements, and post-approval changes.

In addition, DDReg offers specialized regulatory support for medical devices , including classification assessment, establishment registration, and submissions under 510(k), De Novo, and PMA pathways. Our regulatory team works closely with manufacturers to ensure compliance at every stage, from initial classification through approval and post-market obligations.