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SIGNAL
Understanding and globalising drug safety is hard. We simplify the complex.
SCIENTIFIC WRITING, RISK MANAGEMENT & SIGNAL MANAGEMENT
Expert completion of aggregate reports (e.g. DSUR, PADER, PSUR/ PBRER, ACO, CO) in line with applicable templates and guidelines. Support with submission and response to PSUSA.
Expert knowledge of report templates, structures and outputs required to deliver high quality reports to meet regulatory scrutiny.
Assistance with completion of additional modules needed for MA submission/ maintenance/ renewal such as Clinical Overview/ Addendum Clinical Overview.
Clinical study report writing support and assistance.
Risk Management Plan development throughout clinical development phases right up until MA application. REMS development and management. Implementation of RMMs and effectiveness measures.
Development of signal management processes and strategies. Expert delivery of signal management report writing/ analysis. In-depth signal evaluation and assessment.
Expert knowledge of processes and best practice to support with development of robust procedural documents.
EU/UK QPPV SUPPORT
Expert EU/UK QPPVs to meet the EU/UK requirements. Supporting our clients with hands-on experience and dedication to ensure a compliant and healthy PV system. National Contact Representatives for UK are also on hand to provide representation.
STRATEGIC SUPPORT
Expert assistance with strategic overview and planning. Clients seek our help to assist with the below (not exhaustive!):
Review existing processes and ensure efficiency/ compliance
Assist with development of SOPs/ WIs
Devise audit strategy/ plan
Develop RMP strategy and input into MAA submission strategy
Assist with vendor selection/ qualification and management/ auditing of vendors
Implement new regulatory requirements
Prevent audit and inspection findings
Close out CAPAs effectively
Assist with post-merger/ acquisition transition
Devise training plans and assist with delivering a comprehensive training plan
Project manage