Our Services
Comprehensive Associate Regulatory Services
Frequently Asked Questions
Masuu provides specialized regulatory support for pharmaceutical, biotechnology, healthcare, food, cosmetic, and veterinary companies. Our services cover registrations, submissions, certifications, regulatory communications, and compliance activities across global markets.
Yes. Masuu supports US Agent services, DUNS Number, FEI, Facility Establishment Registration, NDC/NHRIC Labeler Code, GDUFA Self-Identification, and Food Facility Registration. We help clients prepare the required information and coordinate applicable regulatory processes.
Yes. Our services include USFDA ESG Portal setup, FDA Submission Form Authorization, Application Number Assignment, Controlled Correspondence, and pre- and post-submission communications. We help clients manage administrative and regulatory requirements efficiently.
Yes. Masuu supports Food Facility Registration, CARES Act submissions, and Cosmetic MoCRA Registration Assistance, depending on the product and applicable requirements. Our team helps clients understand the relevant regulatory pathway and documentation.
Yes. Masuu provides EMA/EDQM SPOR assistance, EU MAH and QP support, IMPD services, REACH registration, and European readability testing. These services help companies address regulatory and market-entry requirements across Europe.
Yes. Masuu supports ANDS/DIN filing, Pre-ANDS meetings, Drug Establishment Licence (DEL) requirements, and other applicable Health Canada activities. Our team assists with documentation, regulatory coordination, and submission-related requirements.
Yes. Masuu provides Brazil submission support along with regulatory assistance for emerging and international markets. Our approach is adapted to the applicable country’s submission format, registration process, and regulatory expectations.
Yes. Masuu provides Certificate of Pharmaceutical Product support for companies that require regulatory certification for international registration. We assist with the applicable documentation and coordination required for the certification process.
Masuu supports PDE, OEL, and OEB value reports through toxicological expertise, along with QSAR-related assessments and MSDS support. These services help companies address occupational exposure, product safety, and regulatory documentation requirements.
Yes. Masuu provides Environmental Risk Assessment (ERA) and EPA Registration assistance for applicable products. Our team helps clients prepare the necessary regulatory information and address environmental requirements relevant to the target market.
Yes. Masuu provides Global Language Translation Assistance for regulatory documents, product information, labeling, and other market-specific materials. The service helps companies prepare documentation suitable for different languages and regulatory markets.
Yes. Masuu provides assistance related to EU Marketing Authorisation Holder (MAH) and Qualified Person (QP) requirements. Our support helps companies understand applicable responsibilities and maintain appropriate regulatory arrangements for European operations.
Yes. Masuu supports both Pre-ANDS meeting preparation and ANDS/DIN filing activities for applicable products. We help clients organize regulatory information, prepare documentation, and coordinate activities according to Health Canada requirements.
Masuu supports Investigational Medicinal Product Dossier (IMPD) activities, Pre-Launch Activities Importation Requests (PLAIR), and WHO Prequalification requirements. These services help companies address specific regulatory pathways for clinical development, product introduction, and international procurement.
Yes. Masuu provides REACH Registration and QSAR assistance for applicable substances and products. Our team helps clients address regulatory data and assessment requirements relevant to chemical and pharmaceutical products.
Yes. Masuu provides readability testing support for labeling and package leaflets intended for European markets. This helps companies assess whether important product information can be understood effectively by the intended users and meets applicable requirements.
Yes. Masuu provides Veterinary Non-eCTD Electronic Submission (VNeeS) support for applicable veterinary medicinal products. Our team assists with preparing and managing electronic regulatory submissions according to the requirements of the target market.
Yes. Masuu provides Pharmaceutical Advertising Advisory Board (PAAB) support for applicable pharmaceutical promotional materials and regulatory requirements. Our team helps companies address the relevant review and compliance considerations for pharmaceutical advertising.
Yes. Masuu supports specialized regulatory requirements such as Affordable Care Act (ACA) Section 6004 activities, along with other market-specific compliance services. Our team assesses the applicable requirements and supports clients with the necessary regulatory documentation and processes.
Yes. Masuu offers a broad portfolio covering USFDA, Health Canada, European, Brazilian, veterinary, environmental, toxicology, chemical, and global regulatory requirements. From registrations and submissions to certifications, correspondence, translations, and specialized compliance activities, our team provides coordinated support based on the client’s product and target market.