Clinexel Life Sciences Pvt Ldt
is a full-service Clinical Research Organization providing clinical research, clinical development strategies, regulatory affairs, medical writing, and pharmacovigilance services, incorporated in India in January 2019, with head office in Navi Mumbai. Their’s international clients include 20 plus pharma companies, primarily small biotech, specialty generic and mid-size pharma companies.
CLINEXEL has experience of supporting these companies for early clinical development phase (innovative niche products including new chemical entities, repurposed drugs and biologicals). They have also solid experience of supporting medical device companies for compliance with EU Medical Device Regulations, including preparation of Clinical evaluation Reports, preparation of PMCF plans and conducting PMCF studies.
CLINEXEL Pharmacovigilance services include processing and submissions of ICSRs, periodic / aggregate reports, signal management, literature monitoring, authoring DSURs, PBRERs and RMPs .
Clinical leadership includes physicians, doctorates, and pharmacists with average industry experience of more than 15 years