K R I D H A P H A R M A

KRIDHA PHARMA

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eCTD

eCTD

eCTD

    Expertise in All Types of Electronic Submissions:

    • eCTD, NeeS & Paper/NeeS to eCTD
    • For US, EU, Canada, Swiss, and GCC
  • Proficiency in eCTD Submission Management, Planning, Publishing Strategy, and Repository
  • Global Assistance in Submission Management, Document Level (DLP), and Submission Level Publishing (SLP)
  • Support for Industry-Wide Harmonization of Electronic Submissions (eCTD, NeeS, and pCTD) According to Health Authority Requirements
  • Rigorous Multi-Stage and Multi-Level Review Using eCTD QC Checklist by Expert Reviewers Before Submission Handover to Clients
  • Expert Handling of Last-Minute Changes/Updates in Dossiers and Submissions
  • Constant Project Micro-Management by Team Leads to Ensure Timely Submissions
  • Send Requirements to: info@kridhapharma.com

Submission Management

  • i.e. Data, Document Collection, Analysis and Planning, Initial Kick Start, Source Documents Review and Gap Analysis, Project Management Tracker and Updating the Dossier Documents based on Comments & Feedback with Troubleshooting etc.

Document Level Publishing

  • i.e. PDF conversion, Bookmarks, inter document Hyperlinks, ToC Generation, Page numbering, Internal document review and quality check and document updates based on review etc..

Submission Level Publishing

  • i.e. Data, Document Collection, Analysis and Planning, Initial Kick Start, Source Documents Review and Gap Analysis, Project Management Tracker and Updating the Dossier Documents based on Comments & Feedback with Troubleshooting etc.

Regulatory Labeling

    Expertise in Various Labeling Categories:

    • Clinical Labeling
    • Medical Device Labeling
    • Prescription Drug Labeling
    • OTC Drug Labeling
    • Bulk Ingredient Labeling
    • Cosmetic Labeling
    • Homeopathic Drug Labeling
    • Dietary Supplement Labeling
  • Expert in Pharma Labeling Affairs:
    • Scientific Review, Compilation, and Finalization of Submission Documents
    • Including SmPC & Package Leaflet/Insert (Prescribing Information – PLR and Non-PLR & Medication Guides)
  • Services Include:
    • Development, Proofreading, and Review of Redline, Clean Copy, and Annotated Comparison Reports
    • Artwork Development Such as Creation of Drawings and Specifications for All Artwork Components
    • Content Development in Compliance with Applicable Regulatory Guidelines
    • Regional-Specific Labeling and Updates Including Text and Language Translation Services

Regulatory Affairs

    Expertise in Labeling Package Preparation:

    • Including Package Insert, Medication Guide, Carton, Container Label, and SPL (Structured Product Labeling)
  • Specialized Team for Conversion of FDA-Compliant and Validated SPL Files (XML):
    • Using Package Insert/Medication Guide (Clean Copy and Comparison Document)
  • Conversion Services Include:
    • Drug Labeling
    • NDC Label
    • Establishment Registration
    • GDUFA Identification in SPL XML Format
  • Utilization of Pre-Defined, Tested, and Validated XML Templates for Various FDA SPLs
  • Effective Life Cycle Management of SPL (Version and Set ID) Adhering to FDA Specifications
  • Rigorous Multi-Stage Review of COL, PDP, and DLD Sections of SPL:
    • Covering Set ID, Version Number, DUNS Number, NDC, Registrant, Labeler, and Establishment Information
    • Ensuring SPL Validation in Compliance with FDA Standards with Zero Errors

Regulatory Affairs

  • Expertise in Drafting Controlled Correspondences, Regulatory Strategy, and White Papers
  • Proficiency in Pre-Approval (Original Application & Amendments) and Post-Approval (Variations/Supplements & Annual Reports)
  • Support in Identifying Gap Analysis in Dossier/Submission During Product Development and Manufacturing
    • Considering Regulatory Authority Requirements and Standards
  • Expertise in Submission Content Writing with Standard and Peer Review for All Pre and Post-Approval Submissions
  • Precise Response and Justification to Health Authorities' Queries
    • Screening All Possible Relevant Queries
  • Strategic Support for Product Selection During Regulatory Planning and Project Finalization
  • Providing US Agent Services:
    • Communicating with FDA for Pre-Request Meetings
    • Handling Queries/Deficiencies in Dossiers
    • Signing Relevant Dossier Documents
    • Updating Establishment Registration Annually
    • Paying Fees for Facilities and Dossiers
    • Dispatching Submissions Through ESG (Electronic Submission Gateway)