Clinical Regulatory Writing

Leverage Indegene's deep domain expertise with regulatory experience across multiple geographies for quality submissions.


Indegene has an extensive track record of providing quality and efficient regulatory services for its clients. These include customizing protocols to meet regulatory approvals, regulatory dossier submissions, marketing approval and authorization, as well as briefing document and label updates, all of which require a thorough understanding of different templates and requirements for local labels to ensure health authority approval on time.

Indegene’s greatest strength is in its large pool of trained scientific and medical talent consisting of postgraduates/doctors/MDs, MBBS with expertise in industry, regulatory, research, clinical practice, and academia. Indegene’s multinational presence and multilingual translation capabilities set it apart as a “global partner” to address the geographic-specific local needs.
 

Indegene's Clinical Regulatory Writing service offerings include:

 

  • Pre-study Documents

    • Clinical Trial Application

    • Clinical Trial Protocols—Phase I to IV

    • Investigator’s Brochures and Updates to Investigator’s Brochures

    • Informed Consent Documents—Informed Consent Form and Patient Information Sheet

    • Protocol Posting/Web Disclosure

  • Post-study Documents

    • Clinical Study Reports: Synopsis, Abbreviated, Interim, and Final

    • Safety/Patient Narratives

    • Briefing Document

    • CTD Modules 2.5 Clinical Overview

    • CTD Modules 2.7 Clinical Summaries, ISS/ISE

    • CTD Modules 5.2 Tabular Listings of Clinical Studies

    • Responding to Health Authority Queries

    • Updates to Approved Dossiers

    • Customizing Completed Dossiers for Regional Submission

  • Product Label

    • Label Preparation and Updates—CDS, USPI, SmPC, and LPDs

    • Repeat Labeling—Update Local Label Based on Primary Label Update

    • Label QC

    • Reconciliation of Local Labels and Master Labels

  • Medical Devices

    • Clinical Investigation Plan and Clinical Evaluation Plan (CEP)

    • Preparation of 510 (k) and PMA

    • Clinical Study Report and Clinical Evaluation Report (CER)

    • Preparation of CE Marking Documents