Our medical writers and safety scientists prepare high-quality aggregate safety reports that clearly communicate a product's evolving benefit-risk profile to health authorities worldwide.
PSUR (Periodic Update Safety Report)
Preparation and management of PSURs to provide a comprehensive, periodic evaluation of the benefit-risk balance of medicinal products.
PBRER (Periodic Benefit-Risk Evaluation Report)
Development of PBRERs to ensure ongoing assessment of product safety and efficacy, meeting ICH E2C(R2) guidelines.
PADER (Periodic Adverse Drug Experience Report)
Expert compilation and submission of PADERs for US FDA compliance, summarising adverse drug experiences and safety data.
DSUR (Development Safety Update Report)
Preparation of DSURs for investigational products, providing annual updates on safety data during clinical development.
ADCO (Addendum to Clinical Overview)
Creation of ADCOs to supplement clinical overviews with new safety, efficacy or risk information as required by authorities.
RMP (Risk Management Plan)
Development and maintenance of RMPs to proactively identify, characterise and minimise product risks throughout the lifecycle.
SSR (Safety Summary Report)
Preparation of SSRs to provide concise, comprehensive summaries of product safety for regulatory and internal review.
Post-Marketing Surveillance Reports
Preparation of post-marketing surveillance reports to monitor product safety and effectiveness in real-world use.
