Dr.Yuvaraj (Pharm)Ph.D.,D.

Sc
IND,CRAMS,CRO preclinical drug discovery-Smart has emerged as one of the leading East/West
pharma business development companies with expertise in the rest of the world like India,
China, Africa.Yuvaraj is an Independent Drug discovery CRO-QA consultant. He founder and
owner of CDN providing IND,CRAMS,CRO preclinical drug discovery ,Regulatory consultancy to
the Industry. Dr Yuva has experience in the design and implementation of Pre-clinical, Clinical &
Commercial Quality Systems (for both biologic and large/small molecules in organizations).
He held senior management positions in various organizations (CROs and Pharmaceutical
companies). His area of expertise includes Quality Systems & Compliance Audits for GLP, GCP,
GMP, ISO 9001, ISO 15189, ISO 17025 and ISO 27001. He is an expert in the Quality Systems for
computerized data to requirements of GLP, 21 CFR Part 11, GAMP and PIC/S.He has vast
experience of auditing/monitoring preclinical studies, auditing/monitoring bioequivalence
studies (including studies with PK in patients, bioequivalence studies with clinical end-points).
He has experience of auditing clinical studies (Phase I to Phase III) in various therapeutic areas
like oncology, endocrinology, respiratory, CNS etc. Dr Yuvaraj has conducted audits in different
geographical locations in India, africa, Canada and Europe.
Yuvaraj qualifications in medicinal chemistry in PG,research of doctarte areas in preclinical and
clinical cancer mechanism newer molecules in pharmacology division, include being a Certified
Laboratory Assessor (Lead Assessor) on the CSI drug discovery network channel in clinical
groups.Ministry of Science and Technology,Government of India since 2006 for ISO 17025:2005;
a certified quality systems auditor for ISO 9001:2008, certified auditor for Information Security
Management System (ISMS) ISO 27001:2005.Dr Yuva has been awarded as a Chartered Scientist
(C.Sci.) by the Science Council.In his capacity as both a Quality Unit leader and as auditor he has
been responsible for audits & systems development, pre-approval audits, development of
compliance policies and procedures for product development. His rich expertise lies in preparing
organisations for successful regulatory inspections while managing internal and external
compliance.Yuva has experience of successfully facing inspections from various Regulatory
Authorities like DCG (I),WHO, ANVISA, EMA, MedSafe, USFDA etc.He has good-people
management, communication, analytical and conflict handling skills. He is an effective trainer,
engaging and mentoring team members. He has demonstrated track record of organizational
leadership and management with an ability to deliver tactical quality solutions.
Dr Yuva is a speaker at various workshops, seminars and conferences.
Professional Membership in varous bodies.
Moks.ra@gmail.com/04445126460