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


    • Drug Master File (DMF)
    Drug Master File (DMF)
    Compilation for open and closed part.

    Drug Master File (DMF) is a master document containing complete information on  API.

    It is a submission to FDA covering factual and complete information on its chemistry, stability, purity, impurity profile, packaging and cGMP status of any API.

    We also perform the following studies, in co-operations to DMF preparation :
    • Structural Elucidation Studies (Elemental Analysis, IR, Mass, NMR C & H, XRD, DSC),
    • Analytical Report (COA)
    • Analytical Method Validation
    • Process Validation
    • Stability data studies
    • Determination & Validation of Potential Impurities & Solvent Impurities
    We have tie-ups with well established labs (NABL Certified) to carry out such analytical testing. (All the data supported by necessary Chromatograms & Spectrums).

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      + 91 22 - 25691939 / 25612751
      enquiry@labeladossier.com