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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.

We provide following Regulatory 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 Applications for Life Cycle Management (new formulations/ indications)
  • Regulatory compliance and gap analysis
  • Development of package inserts and update

Regulatory Writing 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 Applications for Life Cycle Management (new formulations/ indications
  • Regulatory compliance and gap analysis
  • Development of package inserts and update

Medical Writing

  • Preparation of Protocols, Informed Consent Forms, and Investigators’ Brochure
  • Preparation of Clinical Study Reports
  • Authoring Clinical Evaluation Reports including literature search protocol, PICO analysis
  • Post Marketing Clinical Follow-up Plans

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.

LET'S E-MEET

We believe in building long-term client relations with an in-depth understanding of your goals, challenges, and the support required. Let us know if you would like to meet with our technical director to learn more about our solutions to your requirements and potential for collaborations. Travel restrictions due to pandemics have limited our opportunities to meet. Until we can meet in person, let’s connect via Zoom meetings.

Contact us

LET'S E-MEET

We believe in building long-term client relations with an in-depth understanding of your goals, challenges, and the support required. Let us know if you would like to meet with our technical director to learn more about our solutions to your requirements and potential for collaborations. Travel restrictions due to pandemics have limited our opportunities to meet. Until we can meet in person, let’s connect via Zoom meetings.

Contact us

CLINEXEL is a professionally managed private limited company, a CRO led by experts with experience in leadership positions in pharma and biotech companies .

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