Accelerate FDA Services

Trusted Guidance for ANDA, NDA, IND, and DMF Filings - Unleash the Potential of Your Pharmaceutical Products.

Our Proficiency

Elevating Regulatory Success: Unmatched US Agent Expertise

With our proven expertise and experience, Masuu Global offers comprehensive US Agent Services for pharmaceutical and API manufacturers. From regulatory compliance to FDA filings, trust our proficiency to navigate the complex landscape and ensure success in the US market.

Regulatory Strategy Development

Strategic Regulatory Guidance

Our US & Regulatory Agent Services offer expert guidance in developing effective regulatory strategies. We analyze your product portfolio and regulatory landscape to provide tailored strategies that ensure compliance and streamline the approval process. Our comprehensive approach helps you navigate complex regulations with confidence.

Submission Excellence

Timely and Accurate Regulatory Filings

With Masuu Global's US & Regulatory Agent Services, you can expect exceptional support in preparing and submitting regulatory filings. Our experienced team ensures your submissions are accurate, complete, and in alignment with regulatory requirements. We prioritize timeliness to help you meet critical deadlines and expedite the approval process.

Comprehensive Compliance Solutions

Mitigating Risks Effectively

Our US & Regulatory Agent Services encompass comprehensive compliance solutions to mitigate risks effectively. We conduct thorough assessments, audits, and gap analyses to identify potential compliance issues. Through tailored strategies and proactive measures, we help you address risks promptly and ensure compliance with regulatory standards.

Regulatory Updates and Insights

Staying Ahead of Evolving Guidelines

Stay ahead of regulatory changes with our US & Regulatory Agent Services. We continuously monitor and analyze evolving guidelines, keeping you informed of updates that impact your industry. Our experts provide valuable insights and guidance to adapt your strategies, ensuring ongoing compliance and market success.

Expert Liaison with Authorities

Efficient Communication and Representation

As your trusted regulatory partner, we offer efficient communication and expert representation to regulatory authorities. Our team serves as a liaison between your company and regulatory agencies, facilitating clear and effective communication. We handle inquiries, submissions, and interactions, ensuring smooth interactions and maintaining compliance throughout the process.

Our Services

Your Path to Compliance and Success with our Assitance

DUNS Number Registration

Our services include assisting companies in obtaining a DUNS number from D&B, a unique 9-digit identifier for businesses. It is mandatory for all firms and establishments to acquire a DUNS number before initiating their registration with USFDA.

Facility Establishment Registration (ER)

We provide complete assistance for Drug Establishment Registration, including registration and annual renewals between October 1 and December 31. Failure to renew may lead to the firm being marked inactive and removed from the FDA database.

FEI Registration

We provide expert assistance in registering the Facility Establishment Identification (FEI) number with USFDA. The FEI is a distinctive identification number consisting of 7 to 10 digits, issued by the US FDA to facilitate tracking inspections of regulated medical device or drug establishments.

NHRIC/NDC Labeler Code

Our team specializes in the registration and renewal of NHRIC/NDC Labeler Codes with USFDA. The labeler code is a 5-digit number assigned by the USFDA, serving as a unique identifier for each labeler. It is important to note that the NDC Number associated with each drug will vary.

GDUFA Self-Identification

We offer comprehensive support for the registration and renewal of GDUFA self-identification. GDUFA Self-Identification is a mandatory process for drug facilities involved in generic drug submissions. It must be completed annually, specifically between May and June.

CARES Act Submission

We provide professional assistance in submitting CARES reports to USFDA as required by section 510(j)(3) of the FD&C Act. Drug registrants must report annually to FDA on the quantity of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution.

Food Facility Registration

We provide expert assistance for registering and renewing Food Facility (FFR) with USFDA. Registration is mandatory for facilities involved in the manufacturing, processing, packing, or storage of food, beverages, or dietary supplements. FFR registration requires bi-annual renewal between October 1 and December 31.

USFDA ESG Portal Setup

Our professional services cover the setup of the Electronic Submission Gateway (ESG) for secure document submission to USFDA. We provide comprehensive support, including digital certificate procurement, secure email system setup, non-reputation letter preparation and dispatch, test account setup, compliance testing, and facilitating live submissions to USFDA.

Controlled Correspondence

We offer expert assistance in drafting, reviewing, authorizing, submitting, and obtaining approval for Controlled Correspondence (CC) submissions. Controlled correspondence is a process where generic drug manufacturers and related industries request information related to generic drug development before submitting an Abbreviated New Drug Application (ANDA) to USFDA.


Our professional services cater to companies seeking registration and updates of ORG_ID, LOC_ID, and site addresses with European agencies like EU-EMA and EDQM. The SPOR initiative supports EU regulatory activities by providing quality data management services for substances, products, organizations, and referential information.

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