Your Trusted Partner For Clinical Research and Pharmacovigilance

Regulatory Affairs

At CLINEXEL, we provide Clinico-regulatory services including CT dossier preparation & CA approvals, pre-IND dossier preparation & coordination for pre-IND/ scientific advice meetings, IND filing including CC with the Agency.

Talk to Our Experts

CLINEXEL SERVICES

  • Regulatory Consulting and Strategic Services
  • Preparation of Clinical Development Plan
  • Preparation of pre-IND Meeting Dossier,
  • Facilitating Pre-IND and Scientific advisory meetings
  • Filing Clinical Trial Applications
  • Supplemental NDA / Subsequent IND for Life Cycle Management (new formulations/ indications)
  • Regulatory Compliance and Gap Analysis of IND dossiers for IND filing
  • Package Inserts (PI) -new PI development, Maintenance and Updates
woman doctor with stethoscope reading notes from clipboard removebg preview 2
high angle globe with stethoscope peace day removebg preview 2

CLINEXEL EXPERTISE

  • Strong Knowledge of Regulations- India, USFDA, EU, ROW
  • Pre-IND, scientific advice & End of Phase meetings
  • Industry Experience of Clinical Development, Regulatory Meetings, Label Management & Variations
  • Expertise of Hybrid Applications & 505b (2)

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

QUICK LINKS

LET's CONNECT

Our experts will be happy to speak with you to understand your challenges and propose optimum cost-efficient solution.
Write to us at : info@clinexel.com

Contact us

Social Links

Linkedin

Clinexel©2023. All Right Reserved.

Develop by Softtonia