Dossier Lifecycle Management : Masuu offers a comprehensive range of regulatory support services covering various aspects of drug development, approval, and dossier lifecycle management. Following are the specific services offered:

  • Competitive Generic Therapy (CGT) Designation:

    Assistance in obtaining CGT designation, which may provide expedited review and approval pathways for generic drug products.

  • Proprietary Name Request:

    Support in requesting approval for the proprietary name of the drug product, ensuring compliance with regulatory naming conventions and requirements.

  • Pre-facility Correspondence (PFC):

    Support in pre-submission facility correspondence of ANDA as per the reauthorization of the Generic Drug User Fee Amendments (GDUFA III).

  • Information Request (IR):

    Managing and responding to regulatory authorities’ requests for additional information during the review process.

  • Discipline Review Letter (DRL):

    Managing and responding to regulatory authorities’ requests for additional information during the review process for the identifying deficiencies in that particular discipline’s portion of an application to complete the review of the application.

  • Complete Response (CR):

    Managing and responding to regulatory authorities’ request for supporting information to complete response to all of the outstanding deficiencies.

  • Unsolicited Amendment:

    Managing and responding to unsolicited amendment with information not requested by FDA, except for those amendments considered routine or administrative and that do not require scientific assessment.

  • Administrative Amendment:

    Managing and responding to Administrative amendment with information not requested by FDA that are administrative in nature and do not require a scientific assessment that generally not affect the goal date.

  • Patent Information & Verification:

    Assist in Patent Information & Verification of the information submission in the dossiers.

  • Final Review Request (FRR):

    Requesting final review of regulatory submissions prior to approval.

  • Ownership Transfer/Acceptance:

    Support in Ownership Transfer/Acceptance of the facilities or the applications.

  • Pre-submission facility correspondence of ANDA:

    Supports for pre-submitting sections of the ANDA containing facility information to the Agency ahead of ANDA submission.

  • Annual Report (AR):

    Preparation and submission of annual reports to regulatory authorities.

  • Product Correspondence:

    Handling correspondence with regulatory authorities related to the product, including inquiries and notifications.

  • Promotional Labeling Advertising (OPDP – Ad-Promo):

    Ensuring compliance with regulations governing promotional labeling and advertising activities.

  • Periodic Adverse Drug Experience Report (PADER):

    Preparation and submission of periodic reports on adverse drug experiences to regulatory authorities.

  • Change Being Effect-0 (CBE-0)/Change Being Effect-30 (CBE-30) and US Prior Approval Supplement (PAS):

    Supports for supplements submitted after the approval of an ANDA to make changes from what was originally approved Types of supplements are CBE-0, CBE-30, and PAS.

  • Amendment/MoHs Query Response (Day 0, 70, 100, 105, 106, 120 etc.):

    Handling responses to queries and amendments from regulatory authorities at various stages of the review process. Masuu Global is specialize in Regulatory Dossier Queries Management, ensuring efficient handling of queries received from health authorities. Upon receiving queries, our team of Subject Matter Experts (SMEs) conducts a thorough regulatory assessment to determine the required documents for response and collaborate closely with various departments within pharmaceutical companies to gather the necessary revised documents then prepare proper justifications against each query, ensuring compliance with regulatory requirements. The Regulatory CMC Project Manager prioritize timeliness, ensuring that responses are submitted to the agency before the due date to maintain the product approval goal date.

  • Variation Type IAIN, IA, IB, II:

    Managing variations to regulatory dossiers according to different types and levels of changes.

  • Renewal of Application:

    Renewal of marketing authorization applications as required by regulatory authorities.

  • Repeat Use Procedure (RUP):

    Renewal of marketing authorization applications as required by regulatory authorities.

  • Transfer of a Marketing Authorization:

    Facilitating the transfer of marketing authorization between entities as necessary.

  • Periodic Safety Update Report (PSUR):

    Preparation and submission of periodic reports on the safety profile of the drug product.

  • Withdrawal of a Marketing Authorization:

    Managing the withdrawal of marketing authorization for a product as necessary.

  • Priority Review Request:

    supports for Priority Review Request for the applicable applications related to evidence of increased effectiveness in treatment, prevention, or diagnosis of condition; elimination or substantial reduction of a treatment-limiting drug reaction; documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or evidence of safety and effectiveness in a new subpopulation.

  • Response to Quality Clarification Request:

    Handling responses to requests for clarification on quality-related aspects of the product.

  • Response to BE Clarification Request:

    Handling responses to requests for clarification on bioequivalence-related aspects of the product.

  • Response to Telephone Request and e-mail Request:

    Handling various types of requests and inquiries from regulatory authorities via telephone or email.

  • Supplement to a New Drug Submission (SNDS) and Supplement to an Abbreviated New Drug Submission (SANDS):

    Preparation and submission of supplements to new drug submissions or abbreviated new drug submissions.
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