### Service Description for Pharma Regulatory, Research, and Medical Writing Freelance Services As a dedicated freelance professional specializing in pharmaceutical regulatory, research, and medical writing, I offer high-quality, precise, and industry-compliant services tailored to meet the needs of pharmaceutical companies, CROs, and healthcare organizations. #### **Services Offered:** 1. **Pharma Regulatory Support:** - Preparation of regulatory submission documents (e.g., CTD, IND, NDA, and MAA dossiers). - Development of Investigator’s Brochures (IB), Clinical Study Reports (CSR), and Safety Update Reports. - Review and compilation of regulatory documents ensuring compliance with FDA, EMA, ICH, and other global regulatory guidelines. 2. **Clinical Research Services:** - Clinical trial documentation, including protocols, informed consent forms, and case report forms. - Quality assurance and data review in compliance with GCP standards. - Support in site monitoring, initiation, and follow-up. - Assistance in literature reviews and evidence synthesis for clinical research projects. 3. **Medical Writing Services:** - Creation of peer-reviewed journal manuscripts, conference abstracts, and poster presentations. - Development of patient-centric materials, such as educational leaflets and informed consent documents. - Preparation of pharmacovigilance documents, such as Risk Management Plans (RMP) and Periodic Safety Update Reports (PSUR). - Summarization and analysis of medical records for legal or insurance purposes. #### **Key Strengths:** - In-depth knowledge of pharmaceutical regulations and clinical trial processes. - Strong research and analytical skills with attention to detail. - Proficiency in handling confidential medical and scientific data. - Expertise in creating clear, concise, and engaging content for diverse audiences. - Commitment to delivering projects within deadlines while maintaining the highest quality standards. #### **Why Choose My Services?** With hands-on experience in clinical research and medical writing, I bridge the gap between science and compliance, ensuring that your documents meet both regulatory and scientific requirements. My goal is to help you streamline your workflows, enhance document quality, and achieve your project objectives effectively.