Pre/Post Correspondence and Authorized Communication

Pre/Post Correspondence involves managing regulatory communication between the USFDA and pharmaceutical or life sciences companies before and after regulatory submissions. Masuu US Agent acts as an authorized communication channel for foreign companies where applicable.

A US Agent can help facilitate communication between a foreign establishment and the USFDA, including receiving and responding to regulatory communications. Masuu US Agent supports companies in managing these interactions efficiently and maintaining clear communication with FDA.

Masuu can support correspondence related to DMFs, ANDAs, INDs, NDAs, cosmetic products, OTC monograph products, food products and registrations, 510(k) applications, and medical device listings, depending on the applicable FDA requirements.

A Discipline Review Letter (DRL) is a type of FDA communication that may identify questions, deficiencies, or additional information needed during the review of a submission. Masuu can help coordinate the communication and support the preparation of appropriate responses.

An Information Request (IR) is issued when FDA requires additional information or clarification during the review of a regulatory application or submission. Masuu helps communicate the request to the applicant and coordinate the required response.

When FDA issues a Complete Response Letter (CRL), Masuu can facilitate communication with the agency and support the company in understanding the identified deficiencies and coordinating the submission of required responses or additional information.

Yes. Masuu supports regulatory communication during both initial submission and post-submission stages, including responding to FDA questions, providing additional information, and coordinating communications required throughout the lifecycle of an application.

Yes. Masuu US Agent can communicate with the USFDA to coordinate and schedule inspections or audits for foreign pharmaceutical companies. This helps companies manage FDA interactions and prepare for applicable regulatory inspections.

Masuu can support communication related to pharmaceuticals, APIs/DMFs, generic and innovator drugs, cosmetics, OTC products, food registrations, and medical devices, including applicable 510(k) and device listing activities.

Masuu provides end-to-end support for FDA correspondence by receiving and communicating regulatory queries, coordinating responses, facilitating additional information submissions, and supporting inspection-related communication. This helps foreign companies maintain clear, timely, and organized interactions with the USFDA.