Our area of Expertise


Compilation of dossier as per latest country specific guidelines

  • Dossier compilation as per :
    • - Common Technical Dossier (CTD) Guidelines.
    - Asean Common Technical Dossier (ACTD)
       Guidelines.
    - Country specific.

  • Drug master file (DMF) compilation for
        open and closed parts.

  • Drafts data for
    • - BMR, MFR
    - Process Validation,
    - Stability Study reports,
    - Dissolution profile,
    - Certificate of analysis and related reports

  • Reports on
    • - Bioavailability / Bioequivalance Studies,
    - Clinical Trials studies
    - Justification for fixed dose combination
    - Prepare Periodic Safety Update report PSUR).
    - Preclinical studies like Toxicity, subacute,
      acute; Carcinogenicity, Teratology &
      Reproduction toxicity

  • Prepare Summary of product (SPC),
      Pack Insert, Product rationale.

  • Expert Reports
    • - Quality,
    - Pre-clinical,
    - Clinical

  • Overviews (Module 2)
    • - Clinical
    - Non-Clinical

  • Nonclinical Study Reports (Module 4)

  • Clinical Study Reports (Module 5)

  • Ready dossiers available in ACTD, CTD, Asian, African, CIS, Central America, South America, North America.

  • Dossier conversion from one country to another)

  • Registration Assistance

  • Technology Transfer Dossiers Disposable
         Surgical Items


    • Medical Writing Clinical Studies
    We provide services of Medico Writing to Pharma Industry.
    The Medical Writing services cater to the regulatory aspect by searching literature / Published studies / Journal Articles Or buying individual published articles from different sources.

    Service Provided
    • Justification for fixed dose combination.
    • Prepare Periodic Safety Update report (PSUR).
    • Prepare Summary of product (SPC), Pack Insert, Product rationale.
    • Expert Reports on - Quality, Pre-clinical, Clinical
    • Overviews - Clinical / Non-Clinical (Module 2)
    • Nonclinical Study Reports (Module 4)
    • Clinical Study Reports (Module 5)

    Reports prepared

    More than 1000 reports are prepared overall for CIS Countries, Russia, Latin America, African countries, Middle East countries etc.






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      enquiry@labeladossier.com