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Dossier
Preparation

Dossier Preparation

Our team of experts is well aware of your needs as well as the needs of regulatory authorities. To attain quick, hassle-free registration of dossiers, a comprehensive registration knowledge and interpretation of guidelines is most warranted. At SIDDHA Global, we have thorough, comprehensive and up-to-date knowledge about the registration requirements of all MOH and FDA. Moreover, we have an incomparable expertise in filling and filing of dossiers and DMF. We strive to achieve complete client satisfaction by providing inclusive post query support.​

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1. DMF (CTD format) Preparation, Review and Submission

  • A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential and detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • SIDDHA Global provides Global Regulatory Service and DMFs solutions for Pharma Export Registration. We, with our dedicated and skilled technical team, write & review DMF/CTD- Section-3.2.S/QOS as per ICH CTD/ ASEAN CTD/ Country specific guidelines. We also assist in the publishing and submission of USDMF and EDMF to USFDA. We assist our clients during the Product Registration until approval. We provide the support to address the MOH queries received from time to time for other associated applicants if needed.

    • This includes services as:

      • Administration Documentation

      • Technical Documentation

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2. Administrative Documents

  • SIDDHA Global provides Regulatory Consultancy for International Dossier registration with Global geographical regions worldwide. We assist our customers to guide on know-hows about the kind of documents required for a specific country as well as to assist in drafting and finalizing the country-specific administrative documents/CTD Module-1 and help them to minimize the shortfalls in the rejections/Refute -to-file during screening/validation phase of the Dossier submission & review at MOH/FDA.

  • This includes (though, not limited to): 

    • Letter of Authorization Drafting: Letter of Authorization to be submitted as part of DMF/Dossier shall be written, & prepared by us per required format and shall be submitted to Clients for further use.

    • Pack insert / PIL/Summary of Product labelling (SmPC/SPC) – Drafting & Review

    • Prepare label and carton contents,

    • Justification for fixed-dose combination,

    • Global Patent Information and Literature for the patented product

    • Other Administrative (country-specific/ACTD) documents or CTD Module-1 Documents

    • DMF Application, Covering/Transmittal Letter preparation and review.

    • Reviewing of Legal & Administrative Documents: SIDDHA Global's expert team reviews the available administration and legal documents related to DMF filing and assists in the completion of the gaps, as required.

 

3. Technical Documentation (Writing and Review)

  • The technical documentation involves primary documentation which supports an NDA or ANDA in the form of a DMF/ CTD. It compiles the Chemistry, Manufacturing and Controls (CMC) information for the drug substance, as per instructions mentioned in guidance documents from the US Food and Drug Administration (FDA) or the International Conference on Harmonization (ICH). The electronic version of full DMF is submitted to the international associated regulatory agency.

  • The information to be included in the summary of the manufacturing procedure (in the form of a flow diagram) which provides the identification of key raw materials, solvents, and intermediates used during the process. Secondly, the analytical methodology used to assess the drug substance is of critical importance. Moreover, validation reports for the methods for assay, impurities and residual solvents are also included.

  • The comprehensive documentation of DMF involves the following:

    • Preparation of USDMF/EDMF on CTD format & writing of Quality Overall Summary (QOS)

    • Manufacturing and Characterization part of DMF

    • Process validation, AMV & Stability Studies

    • Specification, Method of analysis & Certificate of Analysis of Raw materials

    • Specification, Method of analysis & Certificate of Analysis of API

    • Response to MOH/FDA Queries

    • Technical Package of APIs/intermediate/Bulk Drugs

 

4. Dossier Registration

  • SIDDHA Global is a one-stop Global Regulatory Solution provider that assists their clients in seamless entry into Global regions by getting their products registered as per and well within the expected timelines with minimal anticipated queries with Right-at-first time approach. Support in full dossier writing as well as a review to Clients interested in Pharma Export Business. We prepare, write, review and finally submit the dossiers (as required) as per European/US CTD and ASEAN non-CTD/country-specific requirements to respective Health Authorities.

  • We have experience in guiding the Manufacturer/ Exporter/ Applicant in advance of pre-requisites and Requisites of Registration of product at target country (ies) and assisting them from end-to-end to the registration of their product. This includes:

    • Administrative Documents: SIDDHA Global provides cost-effective Regulatory Consultancy services at your doorstep. Right from International Dossier registration, we assist our clients in achieving successful and timely submission around the globe. Our services include drafting of authorization letter, product labelling summary, preparation of label and carton contents, FDC justifications, etc. We also cater services to review legal & administrative documents.

    • Technical data/sections of Dossier: SIDDHA Global assist its clients in writing and reviewing of all the sections included in a dossier preparation.

 

5. Our services include the following:

  • Writing & Review of Summaries – Quality, Clinical & Non-clinical (Module 2)

  • Writing & Review of Clinical & Non-clinical Overview (Module 2)

  • Writing & Review of PDR, Process validation, AMV & Stability Studies

  • Writing & Review of Specification, Method of analysis & Certificate of Analysis of Raw materials

  • Writing & Review of Specification, Method of analysis & Certificate of Analysis of Formulation product

  • Writing & Review of Module 4

  • Writing & Review of Module 5

  • Reformatting of the dossier to CTD or eCTD by considering gap analysis on the Existing documents/data/dossier as per current requirements.

  • Providing guidance & assistance by working closely with the technical team of Clients towards the generation of adequate data for successful submission of the Dossier to Country MOH/Health authorities.

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6. Handling of Query Responses

  • To achieve complete client satisfaction, we assist our customers in handling and solving the regulatory queries raised by healthcare authorities. We also provide query responding services. Our salient features include the following:

  • Assistance in timely Query-Response to the Regulatory Agencies – Review of queries, timely correspondence with agencies, discussion, planning and follow-up with the clients for the generation of additional data as required.

  • Response preparation and timely submission of query responses to health authorities.

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