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Dossier Filing

Dossier Filing

The Dossier Filing is the crucial step in Product Registration of the Pharmaceutical. The dossier is filled in the eCTD Format. The eCTD is ICH approved and followed by the major of Countries. The various kind of the data is needed to submit in the eCTD. Data of Safety, efficacy, toxicity is needed to be submitted.

Module 1-Administrative Information and Regional Information

  • Application Form: This could provide information on the type of application (new drug application, supplemental application, etc.) as well as the application number and submission date.
  • Application Information: Details about the submitter or applicant, such as name, address, phone number, and any pertinent identifiers (e.g., registration numbers).
  • Supporting Documentation: Any additional documentation relevant to the administration of the submission, such as cover letters, transmittal forms, or administrative checklists.
  • Regional information– The Information related to the manufacture is included in it. The name of manufacture, address is provided in it.
  • Cover letter

Module 2 –Summaries

  • Administrative Information: This includes administrative details such as the table of contents, regional administrative information, and any relevant acknowledgments or appendices.
  • Quality Overall Summary (QOS): The QOS provides a comprehensive summary of the quality information of the drug product, including its manufacturing process, controls, specifications, stability data, and any other pertinent quality-related information
  • Nonclinical Overview: This section summarizes the nonclinical studies conducted to evaluate the safety of the drug. It covers pharmacology, pharmacokinetics, and toxicology data obtained from animal studies, as well as any relevant data from in vitro studies.
  • Clinical Overview: The clinical overview provides a summary of the clinical studies conducted during the drug development process. It includes information on the study designs, patient demographics, efficacy results, safety data, and any other relevant clinical trial information.
  • Nonclinical Summaries: This section provides detailed summaries of individual nonclinical studies, including study objectives, methodologies, results, and conclusions.
  • Clinical Summaries: Like nonclinical summaries, this section provides detailed summaries of individual clinical studies, including study designs, patient populations, efficacy and safety results, and conclusions.

Module 3 – Quality Data

  • Drug Substance: This section provides comprehensive information on the drug substance used in the pharmaceutical product. It includes details on the physical, chemical, and pharmaceutical properties of the drug substance, as well as its manufacturing process, controls, and specifications.
  • Drug Product: Like the drug substance section, this part focuses on the drug product itself. It includes detailed information on the formulation, manufacturing process, controls, specifications, and packaging of the finished pharmaceutical product.
  • Pharmaceutical Development: This section outlines the pharmaceutical development studies conducted to design the drug product formulation and manufacturing process. It includes information on formulation studies, process development, and optimization, as well as the rationale behind formulation and process decisions
  •  Control of Excipients: If excipients are used in the formulation of the drug product, this section provides information on the selection, characterization, and control of these excipients to ensure their quality and compatibility with the drug substance.
  • Manufacturing Process: Here, the manufacturing process of both the drug substance and drug product is described in detail. This includes information on the equipment used, critical process parameters, in-process controls, and validation of the manufacturing process.
  • Control of Drug Product: This section details the quality control tests and specifications applied to the drug product to ensure its identity, strength, purity, and quality throughout its shelf life. It includes information on analytical methods, specifications, and stability studies.

Module 4-Non-clinical Data

  • Pharmacology Studies: Detailed reports on pharmacology studies investigating the drug’s mechanism of action, pharmacokinetics, pharmacodynamics, and any relevant pharmacological effects observed in animal models.
  • Toxicology Studies: Comprehensive reports on toxicology studies designed to assess the potential adverse effects of the drug candidate. This includes acute, subacute, sub chronic, and chronic toxicity studies conducted in various animal species. Additionally, specific toxicology studies may be conducted to evaluate reproductive toxicity, genotoxicity, carcinogenicity, and organ-specific toxicity. 
  • Safety Pharmacology Studies: Reports on safety pharmacology studies aimed at assessing the effects of the drug candidate on vital physiological systems, such as cardiovascular, respiratory, and central nervous systems.
  • Local Tolerance Studies: If relevant, data from studies evaluating the local tolerance of the drug candidate following administration via different routes (e.g., oral, intravenous, dermal) may be included.
  • Pharmacokinetics Studies: Detailed pharmacokinetic data obtained from animal studies, including absorption, distribution, metabolism, and excretion profiles of the drug candidate. These studies provide insights into the drug’s bioavailability, half-life, and metabolism in preclinical models.
  • Immunotoxicity Studies: Data from studies assessing the potential immunotoxin effects of the drug candidate, including its impact on the immune system function and response.

Module 5 –Clinical Data

  • Clinical Study Reports (CSRs): These are comprehensive documents that summarize the results and findings of clinical trials conducted during the drug development process. CSRs typically include detailed descriptions of the study design, patient demographics, efficacy and safety results, statistical analyses, and conclusions.
  • Summary of Clinical Efficacy (SCE): Like the SCS, the SCE summarizes the efficacy data from clinical trials, including primary and secondary endpoints, statistical analyses, and other relevant efficacy-related information.
  • Summary of Clinical Safety (SCS): This document provides a concise overview of the safety data from clinical trials, including adverse events, laboratory findings, and other safety-related information.

OMC Medical will help to compile the Data for the Dossier filling for the Drug Registration. We will be partnering with you for providing the guidance for the dossier filling. We have expert people who will be providing the guidance and will be engaged in the preparation of the Dossier of the drug Product.