Contact :  + 91 22 - 25691939/25612751
Email Us :  enquiry@labeladossier.com










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

    • Regulatory Submissions

    We drive business consultancy on various related to product selection, fixing the price, Appointment importer, Information on rules and regulations, market conditions, competition, product viability, We also offer our best services and supports for your business expansion to the following countries

    South East Asia : Vietnam, Cambodia, Myanmar, Philippines, Indonesia, Sri Lanka
    African Countries : Kenya, Uganda, Tanzania
    CIS Countries : Kyrgyzstan, Uzbekistan, Ukraine, Russia.

    We undertake the full project i.e after careful market survey we select products of priority for registration and also provide complete regulatory support till the registration stage
    • Company registration in getting brand search and registered wherever mandatory.
    • Preparation of medical dossiers for registration of medical products.
    • Translation of Medical dossier into the local language before submission of documents to the Health Ministry for product registration.
    • Handling query if any on your behalf
    • Execution of registration process until the procurement of registration certificates.
    • Render the following
      Services :
    • Common Technical Dossier (CTD) Guidelines.
    • Asean Common Technical Dossier (ACTD) Guidelines
    • Country specific
    • Technology Transfer Dossiers
    • Disposable Surgical Items
    • Dossiers compilation
      for submissions in :
    • Asia
    • Africa
    • Central America
    • South America
    • North America


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