Masuu Global excel in Regulatory Review, Authoring & Dossier Compilation services tailored for global health authorities.

Our Regulatory SMEs meticulously review supporting raw documents, ensuring justifications align with health authority requirements and compiling a list of documents needed for the dossier (Module 1 to Module 5). Masuu Regulatory CMC project manager prepares comprehensive gap analysis reports, tracking changes in documents to maintain compliance and collaborate closely with clients, sharing draft dossiers for review, incorporating feedback and updates based on client comments followed by conducting standard and peer reviews by internal CFTs (Labeling, IPR, Analytical, Operations, CMC, Clinical and eCTD Publishing teams), addressing all queries and open issues before finalizing the dossier for eCTD conversion and submission to the health authority.

US ANDA/Generic

An Abbreviated New Drug Application (ANDA) is a submission to the FDA that contains data for the review and potential approval of a generic drug product. A generic drug must be comparable to an innovator drug in terms of dosage form, strength, route of administration, quality, performance characteristics, and intended use. The registration of generics is done through the ANDA filing process using the 505(j) route.

Masuu Global provide comprehensive support to the pharmaceutical industry in navigating the ANDA filing process. Our expertise ensures that the generic drug applications meet all regulatory requirements and standards for successful 1st cycle approval.

  • White Paper Preparation
  • Controlled Correspondence
  • Review/Gap Assessment
  • Dossier Compilation/Authoring
  • Life-Cycle Management (Pre and Post-approval)
  • Labeling (PI, SPL and Labels)
  • eCTD Publishing and Submission
  • US Regulatory Agent Services

US NDA/505(b)(1)/ 505 (b)(2)

The New Drug Application (NDA) process under the US FDA’s 505(b)(1) and 505(b)(2) pathways is crucial for obtaining approval for pharmaceutical products intended for human use. The 505(b)(1) pathway requires full reports on safety and effectiveness. The 505(b)(2) pathway is used for drugs with modifications in dosage form, strength, or route of administration, which have been previously approved under other NDAs.

Masuu Global offers comprehensive support for NDA submissions under both the 505(b)(1) and 505(b)(2) pathways, ensuring your pharmaceutical products meet all regulatory requirements and standards for successful approval.

  • Regulatory Pathway and Strategy
  • Pre-Submission Meeting Support
  • Gap Analysis and Assessment
  • Technical Review of 505(b)(1) NDA and 505(b)(2) NDA Packages
  • Regulatory Support for Pre-approval Submission
  • NDA Post-Approval Lifecycle Management
  • Labeling (PI, SPL and Labels)
  • eCTD Publishing and Submission
  • US Regulatory Agent Services

Global BLA (Biologics/Biosimilar)

The Biologics License Application (BLA) is a critical pathway for the development and approval of biological medicinal products. These products play a vital role in preventing and treating life-threatening and chronic diseases. The regulatory landscape for biologics, particularly advanced therapies like cellular and gene therapy products, is continually evolving, requiring extensive evaluation of quality, safety, and efficacy.

Masuu Global provides extensive support for Biologics License Applications (BLA) and Biosimilar submissions for the global market, ensuring your biological products meet all regulatory requirements and achieve successful approval.

  • Regulatory Strategy Development and Implementation
  • Pre-BLA and Scientific Advisory Meetings with Health Authorities
  • Compilation, Technical Review, Finalization, and Submission of the BLA Package
  • Regulatory Gap Analysis and Due Diligence
  • Regulatory Strategy for HA Queries and Response Preparation
  • Supplements, Annual Reports, and Lot Distribution Reports (LDRs)
  • Labeling (PI, SPL and Labels)
  • eCTD Publishing and Submission
  • US Regulatory Agent Services

US IND

An Investigational New Drug Application (IND) is a formal request to the FDA seeking permission to administer an investigational drug or biological product to humans. Before any new drug or biological product can be shipped across state lines and administered, it must have FDA authorization through an IND. This requirement applies to products not covered by an approved New Drug Application (NDA) or Biologics License Application (BLA).

Masuu Global offers a comprehensive suite of regulatory affairs services to support Investigational New Drug (IND) approval for the global market.

  • Regulatory Strategy and Consultation
  • Regulatory Requirements for IND Submission
  • Regulatory Support for Pre-IND Meetings (Type A, B and C Meetings)
  • Gap-Analysis of IND Drug Developmental Data
  • Preparation, Technical Review, and Submission of CMC, Non-Clinical & Clinical Packages
  • Pre and Original IND Submission
  • IND Amendments
  • Safety Reporting
  • IND Annual Reports
  • Response Submission to Regulatory Queries
  • US Agent Services for IND Filing

Drug Device Combination

A drug-device combination submission is a formal request to the FDA to ensure their safety, efficacy, and regulatory compliance. These products, which combine drugs, devices, and/or biological products, are overseen by the Office of Combination Products (OCP). The FDA’s guidance includes the classification process, regulatory pathways, premarket submissions, and post-market requirements. Key regulatory pathways include New Drug Application (NDA), Biologics License Application (BLA), and Premarket Approval (PMA), with specific guidance on Investigational Device Exemption (IDE) and 510(k) submissions. The FDA emphasizes a thorough assessment of the product’s quality, performance, and clinical impact, mandating clear labeling and robust risk management strategies to address the unique challenges posed by these hybrid products.

Masuu Global offers comprehensive regulatory services for drug-device combination products to ensure compliance with USFDA requirements. These services cover all stages of product development, from initial concept through market approval and post-market surveillance.

  • Regulatory Strategy Development and Product Classification
  • Pre-Submission Meetings and Communications
  • Filing of Investigational New Drug (IND) and Investigational Device Exemption (IDE)
  • 510(k) and Premarket Approval (PMA) Submissions
  • NDA/BLA Compilation (Preparation, Technical Review, and Submission of CMC, Non-Clinical & Clinical Packages)
  • Response Submission to Regulatory Queries
  • eCTD Publishing and Submission
  • Labeling (PI, SPL, Labels and Promotional Material OPDP)
  • US Agent Services for IND Filing

US Drug Master File

Drug Master Files (DMFs) are critical submissions to the FDA that provide confidential, detailed information about facilities, processes, or articles involved in the manufacturing, processing, packaging, and storage of human drug products.

API/Intermediate Type II Drug Master Files (DMFs) are submissions to the FDA that contain detailed information about the drug substance and drug substance intermediates. These submissions ensure that the FDA can evaluate the safety and quality of the drug substance without revealing proprietary information to drug product manufacturers.

Packaging Material Type III Drug Master Files (DMFs) are submissions to the FDA that contain detailed information about the composition, manufacturing, and wwwing of packaging materials. These DMFs ensure that the FDA can evaluate the safety and quality of the packaging materials used in drug products without revealing proprietary information to drug product manufacturers.

Excipients Type IV Drug Master Files (DMFs) are submissions to the FDA that provide detailed information about excipients, colorants, flavors, essences, or materials used in the preparation of drug products. These DMFs ensure that the FDA can evaluate the safety, purity, and quality of these components without revealing proprietary information to drug product manufacturers.

A Biological Master File (BMF) is a comprehensive dossier submitted to regulatory authorities, such as the U.S. Food and Drug Administration (FDA), that contains detailed information about the biological product, its source, manufacturing process, quality control measures, and other relevant data. The purpose of a BMF is to provide regulatory agencies with a complete and thorough understanding of the biological product to ensure its safety, purity, potency, and efficacy.

The BMF includes extensive documentation on the biological material, whether it’s derived from living organisms, such as cells, tissues, or recombinant DNA technology. It details the development process, including preclinical and clinical data, to demonstrate that the product meets rigorous standards for approval.

Masuu Global offers a comprehensive range of Regulatory Affairs services for filing of Drug Master File (DMF) for APIs, intermediates packaging materials, and excipients and biological in the US market.

  • Review/Gap Assessment
  • Dossier Compilation/Authoring
  • Life-Cycle Management (Pre and Post-approval)
  • Bulk Ingredient Listing SPL
  • eCTD Publishing and Submission
  • US Regulatory Agent Services

US Veterinary Master File

A Veterinary Master File (VMF) is a submission to the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of veterinary drugs and drug substances.

Masuu Global offers a comprehensive range of Regulatory Affairs services for filing of Veterinary Master File (DMF) for APIs, packaging materials, and excipients in the US market.

  • CVM ESS (Electronic Submission System) Registration
  • Documents Review/Gap Assessment
  • Dossier Compilation/Authoring
  • Life-Cycle Management (Pre and Post-approval)
  • NeeS Publishing and Submission (CVM eSubmitter)
  • US Regulatory Agent Services

US Veterinary NADA/ANADA

As mandated by the Federal Food, Drug, and Cosmetic Act (the act), a new animal drug may not be sold into interstate commerce unless it is the subject of an approved new animal drug application (NADA), abbreviated NADA (ANADA), or there is a conditional approval (CNADA) in effect pursuant to 21 U.S.C. § 360ccc or there is an index listing in effect pursuant to 21 USC § 360ccc-1 (21 U.S.C. §§ 331(a) and 360b(a)). Under section 512(j) of the act, unapproved investigational new animal drugs may be exempt from the approval requirements of the act.

Masuu Global offers a comprehensive suite of services to support the regulatory approval process for NADA and ANADA submissions.

  • CVM ESS (Electronic Submission System) Registration
  • Processing request to open JINAD or INAD file
  • White Paper Preparation
  • Controlled Correspondence
  • Review/Gap Assessment
  • Dossier Compilation/Authoring
  • Life-Cycle Management (Pre and Post-approval)
  • Labeling (PI, SPL and Labels)
  • NeeS Publishing and Submission (CVM eSubmitter)
  • US Regulatory Agent Services

US OTC Monograph Registration

OTC Over the counter (OTC) drug products can be registered through two main routes: the OTC monograph route or the NDA/ANDA route. Products under the OTC monograph system have predefined formulations, indications, and labeling requirements established by the FDA.

Masuu Global provides end-to-end regulatory support for OTC drug registration, ensuring that your products meet all necessary requirements for a smooth and successful market entry. Our team of experts is dedicated to helping you navigate the complex regulatory landscape with ease, providing you with the confidence that your products are compliant and ready for market.

  • Preparation and Review Strategy for OTC Monograph Route
  • Facility Registration with USFDA (Establishment Registration)
  • FEI (Facility Establishment Identification) Registration
  • NDC Labeler Code Registration
  • US Regulatory Agent Services
  • Preparation and Review of Labels for Drug Listing
  • Preparation of SPL (Structured Product Labeling) for Drug Listing

Cosmetic/MoCRA Registration

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA Cosmetic registration mandates that manufacturers and processors must register their facilities with the FDA and renew this registration every two years. Additionally, they must list each marketed cosmetic product with the FDA, including detailed product ingredient information, and update this listing annually.

Masuu Global’s regulatory expertise ensures that cosmetic companies navigate MoCRA requirements efficiently, facilitating compliance and market entry for their products in the United States.

  • Cosmetic Facility Registration with FDA Under MoCRA
  • Cosmetic Product Listing with FDA Under MoCRA
  • US Regulatory Agent Services
  • Cosmetic Label Compliance
  • Safety Assessment and Toxicological Services

Food/Dietary/Nutraceuticals

FDA guidance for Food, Dietary, and Nutraceutical products encompasses a range of regulations and recommendations aimed at ensuring safety, efficacy, and proper labeling of these products.

Masuu Global’s expertise in food and dietary regulatory affairs ensures that companies meet FDA requirements efficiently and effectively, facilitating market entry and compliance for their products in the United States.

  • Facility Registration with USFDA (Establishment Registration)
  • FEI (Facility Establishment Identification) Registration
  • NDC Labeler Code Registration
  • Food Facility Registration
  • Preparation of GRAS (Generally Recognized as Safe) Report
  • Support in Labeling and Claims
  • Novel Food and Ingredient Registration
  • US Regulatory Agent Services

Medical 510 (K) and Device Listing and CE Certification

Masuu Global’s regulatory services ensure compliance with FDA and international regulations, facilitating the efficient approval and marketing of medical devices globally. Whether it’s preparing 510(k) submissions, navigating IDE requirements, managing device listings, or obtaining CE Certification, Masuu Global provides comprehensive support throughout the regulatory process.

  • Regulatory Strategy Development
  • 510(k) Submissions Dossier Compilation and Submission (Traditional, Special, and Abbreviated)
  • Establishment Registration and Medical Device Listing
  • Medical Device Labeling
  • European CE Marking/ Certification as per EU MDR 2017/745 Regulation
  • US Regulatory Agent Services

EDQM CEP

The Certificate of Suitability (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) certifies that the quality of a substance complies with the requirements of the European Pharmacopoeia and is suitable for use in medicinal products. The CEP 2.0 introduces new requirements for the content of CEP dossiers for chemical purity and herbal drugs/herbal drug preparations. These updated requirements ensure that all critical aspects of manufacturing and quality control are thoroughly documented and compliant with the lawww regulatory standards.

Masuu Global offers comprehensive regulatory services to facilitate CEP submissions certification and compliance.

  • Documentation Review/Gap Assessment
  • Dossier Compilation/Authoring
  • Life-Cycle Management (Pre and Post-approval)
  • eCTD Publishing and Submission

EU/UK/SWISS/Australia ASMF

The Active Substance Master File (ASMF) procedure, previously known as the European Drug Master File (EDMF) procedure, serves a crucial role in pharmaceutical regulation across multiple regions including the EU, UK, Switzerland, South Africa and Australia. Its primary objective is to protect valuable confidential intellectual property and manufacturing know-how of the active substance manufacturer (ASM), while enabling the Applicant or Marketing Authorization (MA) holder to assume full responsibility for the medicinal product and the quality control of the active substance.

Masuu Global provides comprehensive regulatory services for Active Substance Master File (ASMF) filings, ensuring that clients meet regulatory requirements.

  • Documentation Review/Gap Assessment
  • Dossier Compilation/Authoring (Applicant Part/Restricted Part)
  • Life-Cycle Management (Pre and Post-approval)
  • eCTD Publishing and Submission

EU/UK MAA (NP/DCP/CP/MRP)

The EU Marketing Authorization Application (MAA) is the regulatory process through which pharmaceutical companies seek approval to market their medicinal products within the European Union (EU) and European Economic Area (EEA) countries. Depending on the product and its intended market, different procedures can be chosen.

National Procedure (NP):
  • Overview:
    The National Procedure allows a company to apply for marketing authorization in a single EU member state.
  • Process:
    The application is submitted to the national competent authority (NCA) of the chosen member state, which evaluates the dossier based on national requirements.
  • Scope:
    Typically chosen for products intended to be marketed in only one member state or when a company wants to proceed with staggered submissions across different countries.
Decentralized Procedure (DCP):
  • Overview:
    The Decentralized Procedure is used when a company seeks simultaneous marketing authorization in multiple EU/EEA member states.
  • Process:
    One member state acts as the Reference Member State (RMS), and other Concerned Member States (CMS) assess the application in parallel.
  • Scope:
    Ideal for products not previously authorized in any EU member state or for those seeking broad market access across Europe.
Centralized Procedure (CP):
  • Overview:
    The Centralized Procedure involves a single application to the European Medicines Agency (EMA) for approval valid throughout the EU/EEA.
  • Process:
    The EMA evaluates the application in collaboration with experts from all EU member states.
  • Scope:
    Mandatory for certain types of medicines, such as biotechnology products, orphan drugs, and medicines for serious diseases like cancer or HIV/AIDS.
Mutual Recognition Procedure (MRP):
  • Overview:
    The Mutual Recognition Procedure is used when a product is already authorized in one EU member state and seeks authorization in other member states.
  • Process:
    The Reference Member State (RMS) issues an initial authorization, which other Concerned Member States (CMS) then recognize through a simplified procedure.
  • Scope:
    Facilitates market access expansion across the EU while leveraging an existing national authorization.
Masuu Global offers specialized services to support clients throughout the EU MAA process:
  • Regulatory Strategy Development
  • Dossier Compilation and Submission
  • Lifecycle Management (Initial MAA, Amendments, Renewal and Variations)
  • Labeling Package (SmPC and Mockup) with Translation
  • PIL Readability wwwing/Bridging Report
  • Risk Assessment System – RMP (Risk Management Plan)
  • Pharmacovigilance system with SPS (Summary of the PV System)
  • QP Declaration Relation to the API Site
  • Preparation of Pre/Nonclinical Overview (Module 2.4)
  • Preparation of Clinical Overview (Module 2.5)
  • Preparation of Nonclinical Written and Tabulated Summaries (Module 2.6)
  • Preparation of Clinical Summary (Module 2.7)
  • Acting as MAH and Regulatory follow with Health Authorities
  • Acting as Batch Release Site (BRS) and Batch wwwing Site (BTS)
  • Acting as Qualified Person (QP) and MIA (Manufacturer’s/Importation Authorisation)
  • Acting as Qualified Person of PV (QPPV)
  • eCTD Publishing and Submission

Canada NDS

The New Drug Submission (NDS) process is a regulatory requirement by Health Canada that pharmaceutical companies must follow to bring new drugs to the Canadian market. This rigorous process ensures that any new drug is thoroughly evaluated for its quality, safety, and efficacy before it can be approved for public use.

Masuu Global’s regulatory support services for New Drug Submission (NDS) in Canada are designed to streamline the approval process and ensure your drug meets Health Canada’s stringent standards. Our comprehensive services cover all aspects of the NDS process, from non-clinical and clinical data preparation to quality control and lifecycle management. Partner with Masuu Global to navigate the complexities of regulatory submissions and bring your new drug to the Canadian market successfully.

  • Regulatory Pathway and Strategy
  • Pre-Submission Meeting Support
  • Gap Analysis and Assessment
  • Preparation and technical Review of NDS Packages
  • Pre-Submission and Post-Submission Support
  • Labeling (PI, SPM and Labels)
  • eCTD Publishing and Submission

Canada ANDS

An Abbreviated New Drug Submission (ANDS) is a vital step in obtaining marketing approval for a generic drug in Canada. Health Canada, the federal department responsible for national health care, mandates that an ANDS must be approved under the Food and Drug Regulations before a generic drug can be marketed.

Masuu Global’s regulatory support services for Abbreviated New Drug Submission (ANDS) in Canada are designed to facilitate a smooth and efficient approval process for generic drugs. Our comprehensive services cover all aspects of the ANDS process, from filing procedure guidance and strategy preparation to document review and response preparation. Partner with Masuu Global to navigate the complexities of regulatory submissions and achieve successful market entry for your generic drug in Canada.

  • Preparation and Review of ANDS Submission Strategy
  • Pre-Submission Meetings with Health Canada
  • Drug Establishment License (DEL) Application Submission
  • Gap Analysis and Regulatory Assessment
  • Preparation, Review, and Submission of ANDS Package
  • Labeling (PI, SPM and Labels)
  • eCTD Publishing and Submission
  • Pre-Submission and Post-Submission Support

Canada CTA

The Clinical Trial Application (CTA) is a critical regulatory requirement for conducting clinical trials in Canada. Health Canada mandates that a CTA must be approved before the initiation of any clinical trial.

Masuu Global’s regulatory support services for Clinical Trial Applications (CTA) in Canada are designed to streamline the approval process and ensure your clinical trial meets Health Canada’s stringent standards. Our comprehensive services cover all aspects of the CTA process, from pre-clinical trial application consultation and CTA preparation to post-authorization changes. Partner with Masuu Global to navigate the complexities of regulatory submissions and successfully initiate and conduct your clinical trial in Canada.

  • Pre-Clinical Trial Application Consultation Meeting Support
  • Preparation Clinical Trial Application (CTA)
  • Post-Authorization Changes
  • eCTD Publishing and Submission

Australia/GCC/Jordan/South Africa/RoW MAA

Masuu Global offers comprehensive Regulatory Affairs services for Marketing Authorization Application (MAA) submissions tailored to various regions including Australia, GCC (Gulf Cooperation Council), Jordan, South Africa, and other regions globally.

  • Regulatory Strategy Development
  • Dossier Compilation and Submission
  • Lifecycle Management (Initial MAA, Amendments, Renewal and Variations)
  • Labeling Package (SmPC and Mockup) with Translation
  • PIL Readability wwwing/Bridging Report
  • Risk Assessment System – RMP (Risk Management Plan)
  • Pharmacovigilance system with SPS (Summary of the PV System)
  • Preparation of Pre/Nonclinical Overview (Module 2.4)
  • Preparation of Clinical Overview (Module 2.5)
  • Preparation of Nonclinical Written and Tabulated Summaries (Module 2.6)
  • Preparation of Clinical Summary (Module 2.7)
  • Acting as MAH and Regulatory follow with Health Authorities
  • eCTD Publishing and Submission
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