Medical writing
Crafting Precision, Communicating Science
In the pharmaceutical industry, accurate and compliant medical writing is essential for communicating complex scientific and medical information.
At Pro Pharma Research Organization, our Medical Writing Service for Pharma offers comprehensive support to pharmaceutical companies, ensuring that scientific, regulatory, and clinical content is meticulously crafted to meet the highest industry standards.
Service overview
Clinical Study Reports (CSRs)
Preparation of comprehensive CSRs, including summaries of efficacy and safety data, patient demographics, and statistical analyses in compliance with regulatory requirements.
Regulatory Submissions
Crafting regulatory documents for submissions to health authorities, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
Patient Information Leaflets (PILs) and Package Inserts
Development of patient-friendly, clear, and compliant PILs and package inserts, ensuring that patients have access to comprehensible product information.
Summaries of Product Characteristics (SmPCs)
Writing SmPCs that provide concise and comprehensive information about product indications, dosages, contraindications, and adverse reactions for healthcare professionals.
Scientific Articles and Manuscripts
Crafting scientific articles, research manuscripts, and publications for peer-reviewed journals, emphasizing clinical trial findings and scientific advancements.
Clinical Protocols and Informed Consent Forms
Writing clear and comprehensive clinical study protocols and informed consent forms for use in clinical trials.
Medical Review and Safety Narratives
Conducting medical review and preparing safety narratives for adverse event reports and regulatory submissions, ensuring accuracy and completeness.
Regulatory Responses
Preparing scientifically sound and persuasive responses to regulatory queries, ensuring compliance and addressing health authority concerns effectively.
Development Risk Management Plans (RMPs)
Crafting RMPs, including assessment of product risks, pharmacovigilance strategies, and post-authorization safety studies.
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Creating PBRERs that assess the benefit-risk profile of pharmaceutical products, incorporating safety and efficacy data.
Clinical Trial Registration and Results Reporting
Assisting with clinical trial registration on public databases and reporting trial results in compliance with regulations and transparency requirements.
Adherence to Industry Guidelines and Standards
Ensuring that all medical writing is aligned with regulatory guidelines (e.g., ICH E3, E6), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP).
Multilingual Support
Providing translation and adaptation services to create content for diverse global markets.
In the pharmaceutical industry, precision in medical writing is critical for regulatory compliance and effective communication. Our Medical Writing Service for Pharma, offered by Pro Pharma Research Organization, is dedicated to crafting scientifically accurate and compliant content that conveys complex information clearly and concisely. Our commitment to excellence in medical writing ensures that pharmaceutical companies can meet regulatory requirements and effectively communicate their products' scientific and medical attributes to healthcare professionals and patients.
