Your Trusted Partner For Clinical Research and Pharmacovigilance

REGULATORY AFFAIRS

At CLINEXEL, we are providing global clinico-regulatory services to companies for the development of their new chemical entities and biologicals. We support companies by preparing clinical development plans and regulatory strategies and further firming up these through pre-IND and scientific advice meetings. We are also working on subsequent IND projects for Life Cycle Management of pharmaceuticals.

CLINEXEL SERVICES

  • Regulatory consulting and strategic services
  • Preparation of Clinical Development plan
  • Preparation of pre-IND meeting dossier, and facilitating
  • pre-IND meetings and scientific advice meetings
  • Filing of Clinical Trial Application
  • Subsequent IND for Life Cycle Management (new formulations/ indications)
  • Regulatory compliance and gap analysis of IND dossiers for IND filing
  • Development of package inserts and update

CLINEXEL CLIENT SOLUTION

  • Regulatory services to the Clients from USA, Europe, India
  • IND filing, CT filing, subsequent IND
  • Post-approval submissions
  • Working with pharmaceuticals and device companies

CLINEXEL EXPERTISE

  • Strong knowledge of regulations- India, USFDA, EU, ROW
  • Pre-IND, scientific advice & EOP meetings
  • Industry Experience of clinical development, regulatory
  • meetings, Label management & variations
  • Expertise of hybrid applications & 505b (2)

MEDICAL WRITING

Clinexel Services : High-quality documentation in

    • Essential Trial Documents (Protocol, IB, ICD, and CRF)
    • Clinical Study Reports
    • Clinical Evaluation Plans and Clinical Evaluation Reports
    • Literature Review & PICO Analysis
    • Performance Evaluation Plans and Performance Evaluation Reports
    • FAQs, Standard Response Letters, publications, fact sheets

Clinexel Expertise

    • Strong knowledge of GCP & GVP
    • Medical writers with experience of Clinical Operations
    • Well versed with local and international regulations
    • Professional, experienced staff (Ph.D, M.Pharm)
    • Understanding of SOCs & patient management
    • Working with clients from the USA, Europe, India, and Asia
    • Working with pharmaceutics and device companies
    • Interactions with NB for submissions under MDR
    • Presentations for EOP meetings

REPRESENTATIVE SERVICES

Europe

  • QP in Europe
  • EU-QPPV in Europe
  • Local Safety Officers in all Member States of Europe
  • Legal Representative in Europe
  • EU Data Protection Officer

India

  • Legal Representative in India
  • Regulatory Agent in India
  • Data Protection Officer in India
  • PvOI in India and PvMF holder in India

US

  • US Agent

Rest of the World

  • QPPV services in Africa, Middle east countries and CIS countries
  • Regulatory Agent Support in multiple countries.