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KRIDHA PHARMA

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Dossier

Dossier

info@kridhapharma.com

Dossier - CTD, ACTD & ROW

Kridha Pharma: Your Global Leader in Regulatory Consulting and Dossier Solutions for Export Registration

At Kridha Pharma, we specialize in providing top-tier regulatory consulting and comprehensive dossier solutions for export registration. Our expertise lies in crafting and reviewing dossiers that align with various regulatory standards, including CTD/ACTD and Country Specific Guidelines

Prepare, Review And Submit

  • Format: CTD Guideline (EU / ICH / RoW)
  • Module 1 - Administrative Information and Prescribing Information
  • Module 2 - CTD Summaries (Quality Overall Summary, Nonclinical & Clinical Overview)
  • Module 3 - Quality (S part - DMF & P Part - Finished Product)
  • Module 4 - Nonclinical Study Reports (Literature-Based)
  • Module 5 - Clinical Study Reports (Literature-Based)

Writing / Review

  • Registration Application & Covering Letter
  • Letter of Authorization
  • Summary of Product (SmPC) and Pack Information Leaflet (PIL) or Pack Insert
  • Label and Carton Contents
  • Global Patent Information and Literature for Patented Product
  • PSUR (Periodic Safety Update Reports)
  • Legal & Administrative (GMP, CoPP, FSC, etc.) Documents
  • Expert Summaries
  • Site Master File (SMF)

Supportive Services

  • Managing MoH Queries and Dossier Reviews for product registration.
  • Providing translation advice.
  • Drafting and reviewing various agreements.
  • Preparing DMFs in CTD Format.
  • Offering guidance on Bioequivalence Studies.
  • Creating documentation for Process Validation, Stability, PDR, and AMV.
  • Supplying over 600 ready-to-use CTD Dossier Templates.
  • Providing Reference Dossiers, DMFs, and a BE Database.

Prepare, Review And Submit

  • Format: Compliant with ASEAN CTD Guideline
  • Part I: Administrative Information and Product Information
  • Part II: Quality section, including the S part (Drug Master File) and the P part (Finished Product)
  • Part III: Nonclinical Study Reports based on literature
  • Part IV: Clinical Study Reports based on literature

Writing / Review

  • Application for Registration and Covering Letter
  • Authorization Letter
  • Product Summary (SmPC)
  • Package Information Leaflet (PIL) or Pack Insert
  • Label and Carton Contents
  • Legal and Administrative Documents (GMP, CoPP, FSC, etc.)
  • Expert Summaries
  • Site Master File (SMF)
  • Documentation for Process Validation, Stability, Product Development Reports (PDR)

Supportive Services

  • Handling all Ministry of Health (MoH) Queries (up to product registration)
  • Reviewing Dossier as per Updated ASEAN Guideline
  • Writing and Reviewing Agreements (CDA/NDA & Supply)
  • Separate Drug Master Files (in CTD / ACTD format)
  • More than 600 ACTD Dossier Templates (Ready-to-write: to save time)
  • Reference ACTD Dossiers / Drug Master Files / Bioequivalence Database

Prepare, Review And Submit

  • We prepare and review dossiers according to country-specific guidelines.
  • ROW Dossier covers the following parts:
    • Administrative and Legal Part
    • Quality Part
    • Clinical and Toxicity Part

Writing / Review

  • Registration Application & Covering Letter
  • Letter of Authorization
  • Product Documentation (SmPC, PIL, Label, Carton)
  • Legal & Administrative Documents (GMP, CoPP, FSC, etc.)
  • Certificate of Analysis (COA), Manufacturing Agreement (MOA), and Specifications

Supportive Services

  • MoH Query Management (up to product registration)
  • Dossier Review according to Updated MoH Guidelines
  • Agreements Writing & Review
  • CTD-format Drug Master Files (DMF)
  • 60+ Country-Specific Reference Dossier Templates (Ready-to-use)
  • Reference Dossiers, DMFs, and Bioequivalence Database