Registered pharmacist with 12+ years of Regulatory and commerical medical writing experience in the pharmaceutical industry. I have experience in writing and managing the common technical documents (CTD) for submissions & publications for pharmaceuticals & research organizations. I also have extensive experience in the writing, quality control and peer review as per the International Council for Harmonisation standards of the following: Module 2 & 3 CMC post approval submissions for global markets • Variations (minor, major, site transfers changes) • Annual reports • Renewals • Health Authorities Queries handling Module 2, 4 & 5 • Clinical Study Reports; • Clinical Evaluation Reports; • Individual patient narratives; • Protocols, including amendments; • INDs-clinical and nonclinical writing; • Global value dossiers. Experienced in writing CMC post approval submissions, global value dossiers, clinical study reports, protocols, case narratives, research papers, journal articles, scientific reviews, short communications, detailing aids, conference & educational materials, and SOPs. • United Kingdom (UK) contracts working experience through UK based recruitment agency. Therapeutic Areas (No Limitations): Respiratory, Topical applications (Dermatology), Cardiovascular, Anti-infectives, Oncology, Immuno-oncology, Diabetes, Musculoskeletal, Vaccines, Rheumatology. Deepti Kaushik Consultant Medical Writer deepti.zonap@gmail.com; deeps4u27@gmail.com