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Hire Dr. Navaneethan P.

India

Pharmaceutical Analytical Research Expert with Two Decades of Experience | PhD in Analytical Chemistry

Profile Summary

Pharmaceutical Analytical Research Expert with Two Decades of Experience. Thorough knowledge of analytical requirement for all regulated market US, EU, Australia, Brazil, Japan etc.,. More than 50 ANDA products regulatory deficiency was handled independently. Providing end to end support for all analytical related activity, method development, method validation, stability and method transfer in different phases of product development. Hands on experience of solid dosage forms and Injectable dosage forms. Expertise on discriminate dissolution media selection for solid oral product, establishing leachability and extractability co-relation for injectable product, ICH Q3D risk assessment establishment for all dosage forms considering the toxicity nature, reverse engineering (deformulation) study for innovator product, polymorphic study and assessment for form depended products w.r.t bio availability. Implementing the good practice of CGMP compliance w.r.t change requisition, deviation, vendor qualification, source approval and CAPA. Scientific establishments and root cause identification for OOT and OOS of ANDA and Commercial batches. Good knowledge of Life Cycle Management product in terms of alternative source selection and assessment for type of variations in EU market and identifying the filing strategy w.r.t CBE 30 or PAS for USA market.

Subject Matter Expertise

• ★ Analytical Chemistry

Services

• Consulting
• Data & AI

Consulting Scientific and Technical Consulting

Work Experience

Head Analytical Research

Jubilant Generics Ltd

April 2014 - January 2021

Education

PhD Chemistry

Anna University, Chennai

January 2008 - January 2013

Certifications

• Certification details not provided.