Clinical
Development
Regulatory Strategy
Experts in FDA, EMA and EHA regulations for drugs and medical devices
Medical and Scientific Writing
Briefing documents, protocols, clinical study reports, informed consent forms, investigators’ brochures, annual reports
Clinical Data Management
NIH’s clinicaltrials.gov and EudraCT data management. Stay compliant with Food and Drug Administration Modernization Act (FDAMA)
eCTD Publishing
Compile, publish and validate with our FDA compliant systems. Submit via Electronic Submissions Gateway (ESG)
Risk and Compliance Management
Actionable inspection readiness, proactive GCP compliance and effective risk management
Pharmacovigilance
Drug safety services, pre & post-marketing safety surveillance, monitoring, assessing and analyzing information
Project Management
Set the stage for your project success through every step of the product life cycle
Auditing
Identify and manage your risk as early as possible with mock audits, inspection readiness activities, site visits, and CAPA reports
Custom Services
FDA’s expanded access program (compassionate use) of investigational drugs, biologics or medical devices
Patient Recruitment
Increase participation of racial and ethnic minorities in clinical studies