Clinexel is a team of 45 Subject Matter Experts (SMEs) who are professionally qualified, with industry experience in pharmacovigilance, regulatory affairs, medical writing and clinical trial services. Clinexel experts include 4 physicians, 2 PhDs, 18 Pharmacists and life sciences post graduates.

Clinexel Pharmacovigilance experts have hands-on experience of authoring PBRERs, DSURs, PADERs, Signal Assessment Reports, RMPs, HHA Reports for various clients. Clinexel physicians conduct medical reviews of ICSRs/ SAEs, SUSAR line-listings and prepare AOSE reports.

Clinexel Medical Writing team includes 2 PhDs, 4 Pharmacists and 1 MSc. We are providing services for regulatory medical writing including drafting protocols, ICFs, Clinical Study Reports, IBs and other essential documents. We also author manuscripts for publications.

Clinexel Regulatory Affairs and clinical trials team provides regulatory, site selection and trial monitoring services in India.

Dr Deepa Arora, CEO, is a physician, >20 years of experience. After working for several years as Vice President and Global Head of Drug safety & risk management for a mid-size company, I have started my own pharmacovigilance company in 2019. I fully understand the regulators perspective and compliance requirements for pharmacovigilance globally. I have successfully hosted several GVP and PADE inspections as the most responsible person for pharmacovigilance without any critical or major finding. I have experience in Pharmacovigilance, safety monitoring during clinical development, medical writing, preclinical studies and patient care. I set-up and successfully led efficient and regulatory compliant Global Safety function for two mid-size companies. I was a key member for clinical development and safety management of NCEs and biosimilars in 3 companies.

Now, I’m looking forward to supporting pharma companies as Consultant for- Development of Pharmacovigilance strategy & planning; Pharmacovigilance inspection readiness; Potential acquisitions Due diligence, Gap Analysis of potential acquisitions; Advise/ lead on integration and merger of new acquisitions or multiple databases; Support for setting-up of compliant, efficient, cost effective in-house PV department or specific PV processes; Gap Analysis: Review of the current processes; Preparation & Training of SOPs; Pharmacovigilance Inspection Remediation including post inspection support in preparation of the response and planning and implementation of CAPAs; pharmacovigilance auditing & conducting mock inspections and safety monitoring in clinical development.