Bringing a pharmaceutical product to the U.S. market requires rigorous regulatory approval by the U.S. Food and Drug Administration (FDA). For drug manufacturers, this process involves filing either an Abbreviated New Drug Application (ANDA) for generic drugs or a New Drug Application (NDA) for novel, innovative drugs.

The ANDA pathway is designed for companies developing generic drug products that are bioequivalent to approved reference drugs. Successful ANDA approval allows manufacturers to market cost-effective generic versions while maintaining FDA’s strict standards for safety, efficacy, and quality.

The NDA pathway, on the other hand, is required for new and innovative drugs that have not previously been approved in the U.S. market. An NDA submission must include extensive data from preclinical studies, clinical trials, manufacturing processes, labeling, and safety assessments. Approval through this route grants companies the ability to commercialize groundbreaking pharmaceutical products in the U.S.

Both ANDA and NDA submissions must be compiled and submitted in the electronic Common Technical Document (eCTD) format, which requires technical expertise and strict compliance with FDA submission standards.

At XPRO America, we specialize in guiding pharmaceutical companies through the ANDA and NDA submission process, ensuring that applications are complete, compliant, and submitted successfully. Our services include:

• Strategic planning for ANDA & NDA submissions
• eCTD compilation and publishing in line with FDA requirements
• Guidance on bioequivalence studies for generics
• Support in compiling clinical and preclinical data for NDAs
• Labeling compliance to meet FDA standards
• Communication support during FDA review cycles

With our expertise, drug manufacturers can streamline the complex submission process, avoid delays, and increase their chances of FDA approval. Whether you are filing a generic ANDA or a novel NDA, XPRO America provides the regulatory support needed to bring your pharmaceutical products to the U.S. market with confidence.

XPRO America provides expert support for FDA ANDA & NDA submissions, including eCTD compilation, bioequivalence studies, and full regulatory guidance.