Expert preparation and submission of Medical Device Reports (MDR) in compliance with global regulatory requirements, ensuring timely and accurate reporting of device-related adverse events.
Preparation and management of PSURs to provide a comprehensive, periodic evaluation of the benefit-risk balance of medicinal products.
Development of PBRERs to ensure ongoing assessment of product safety and efficacy, meeting ICH E2C(R2) guidelines.
Expert compilation and submission of PADERs for US FDA compliance, summarizing adverse drug experiences and safety data.
Preparation of DSURs for investigational products, providing annual updates on safety data during clinical development.
Creation of ADCOs to supplement clinical overviews with new safety, efficacy, or risk information as required by authorities.
Development and maintenance of RMPs to proactively identify, characterize, and minimize product risks throughout the lifecycle.
Preparation of SSRs to provide concise, comprehensive summaries of product safety for regulatory and internal review.
Management and reporting of product quality complaints, ensuring compliance with regulatory standards and rapid resolution.
Preparation of post-marketing surveillance reports to monitor product safety and effectiveness in real-world use.
Expert assessment and documentation of health hazards, supporting regulatory submissions and risk mitigation strategies.