Trusted Guidance for ANDA, NDA, IND, and DMF Filings - Unleash the Potential of Your Pharmaceutical Products.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
Masuu Global's US regulatory agent services have been invaluable in guiding us through the complex regulatory landscape. Their expertise and support have ensured our compliance and successful submissions. Highly recommended!
We are extremely pleased with the US regulatory agent services provided by Masuu Global. Their knowledgeable team has been instrumental in navigating the regulatory process, saving us time and resources. Their commitment to our success is evident in their exceptional service.
Masuu Global has been an excellent partner as our US regulatory agent. Their professionalism, attention to detail, and prompt communication have exceeded our expectations. We have complete confidence in their ability to handle our regulatory needs effectively.
I want to express my gratitude to Masuu Global for their exceptional US regulatory agent services. Their in-depth knowledge and understanding of FDA regulations have been instrumental in achieving regulatory approval for our products. Their dedication and support have been invaluable to our company's success.
Let our experts guide you through the complex FDA requirements. Contact us today!Contact Us