Medical writing regulatory compliance accuracy

Create accurate medical writing that meets regulatory standards and communicates complex information clearly. Regulatory requirements: 1. FDA guidelines: clinical trial reports, drug labeling, safety documents. 2. ICH-GCP: Good Clinical Practice standards for international trials. 3. EU regulations: EMA requirements, GDPR compliance for patient data. 4. Institutional Review Board (IRB): protocol submissions, informed consent forms. Document types: 1. Clinical study reports: methodology, results, statistical analysis. 2. Regulatory submissions: NDAs, BLAs, marketing applications. 3. Medical communications: publication manuscripts, congress abstracts. 4. Educational materials: physician guides, patient information leaflets. Writing principles: 1. Accuracy: precise medical terminology, current research citations. 2. Clarity: complex concepts explained for target audience. 3. Objectivity: unbiased presentation of data, balanced risk-benefit. 4. Completeness: comprehensive coverage without critical omissions. Quality assurance: 1. Medical review: physician verification of clinical content. 2. Regulatory review: compliance specialist approval. 3. Editorial review: clarity, consistency, grammar checking. Source verification: peer-reviewed journals, clinical databases, expert consultations. Timeline management: regulatory deadlines, submission windows, review cycles.