Regulatory Services
Medicosurg Solutions is a premier partner for Sponsors and CROs, delivering high-performance Site Management (SMO), Phase I-IV Clinical Trials, and BA/BE Studies. We ensure operational excellence through strict adherence to ICH-GCP, GLP, and global regulatory frameworks.
Medical Writing
We provide end-to-end documentation support for the entire clinical development lifecycle:
Investigator Brochures (IB): Comprehensive annual updates and initial compilations that provide investigators and Ethics Committees with a clear rationale for the study.
Clinical Study Reports (CSR): Drafting of Phase I-IV reports according to ICH E3 standards, ensuring accurate representation of safety and efficacy endpoints.
eCTD/CTD Module Development: Authoring and structured formatting of Common Technical Documents (Modules 2.5 and 2.7) for IND, NDA, and ANDA submissions to global health authorities.
Protocol & Informed Consent Development: Designing robust, compliant protocols and patient-centric ICFs to ensure ethical trial conduct and high-quality data collection.
Safety Narratives: Drafting concise, detailed patient narratives for Serious Adverse Events (SAEs) and deaths, ensuring they are “submission-ready” for regulatory dossiers.
Integrated Pharmacovigilance (PV) & Drug Safety
We provide end-to-end safety oversight from early-phase trials to post-market surveillance, ensuring compliance and patient safety. Our approach combines continuous monitoring, advanced reporting, and alignment with global regulatory standards.
Continuous Surveillance: Proactive monitoring of safety data to detect trends early, enabling timely updates to the Reference Safety Information (RSI).
PBRER & PSUR: Authoring of Periodic Benefit-Risk Evaluation Reports and Periodic Safety Update Reports for post-marketed products, aligning with ICH E2C (R2) standards.
Risk Management & Mitigation
Risk Management Plans (RMP): Design and implementation of EU-RMP or US-REMS (Risk Evaluation and Mitigation Strategies) to manage identified and potential risks throughout the product lifecycle.
Post-Market Surveillance: Development of proactive strategies for real-world evidence collection to satisfy regulatory commitments and ensure ongoing patient safety