Profile Details

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USD 90 /hr

★★★★★

☆☆☆☆☆

Hire Surya N.

India

USD 90 /hr

CMC Expert with 20+ years of Regulatory and Formulation experience for USFDA, EMEA, Japan, Canada and ROW Markets

Profile Summary

SME (Subject Master Expert) in the Regulatory Affairs and Compliance Development of Finished Formulations (OSD and Injectable) Scientific Advice and Strategy preparation for dossier submissions for Regulated and Semi Regulated markets Due Diligence for Pharma Dossiers Specially CMC and Clinical Regulatory compliance expert Identification of Risks in the regulatory submissions and Mitigation Strategies eCTD Evaluation and Content Writing Deficiency responses for US and Europe etc.. Management of Post Approval Life cycle of products Audit preparedness and support People development through training and Optimisation of resources Keeping things simple, analytical approach to problem solving and application of knowledge to/from/in real life scenarios

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ★ Regulatory Affairs
• ★ CMC Documentation
• ☆ Clinical Trials
• ☆ Regulatory Writing

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Product Development Formulation

Work Experience

Director, Regulatory Affaires

Ipharmed Services Pvt Limited

January 2020 - Present

Education

M.Pharm.

Dr. MGR Medical University, Chennai

March 2000 - March 2002

Certifications

• Certification details not provided.