Our services include:

• Global Pharmacovigilance & Drug Safety Risk Management
• One-Stop Shop For Start-Up & Small Companies
• Clinical Trials Support Services
• Training Services
• Recruitment Services
• Inspection Readiness Services

Global Pharmacovigilance & Drug Safety Risk Management

• Medical assessment of individual case safety reports / raise medically relevant follow-up questions / add medically relevant comment to aid case interpretation / check coding or advise on MedDRA coding
• Cumulative assessment of adverse event data
• Signal detection / issue work-ups / drug safety reports of analyses and investigations of specific issues
• PSUR services
• Pharmacovigilance & Risk Management Plans
• Training
• Pharmacovigilance Audits
• Pharmacovigilance & Risk Management SOPs
• Pharmacoepidemiology support

1 Study designs
2 Database studies
3 Project management

• Issue & Crisis Management





One-Stop Shop For Start-Up & Small Companies

• We can take care of all your pharmacovigilance, devices vigilance and medical affairs
• EU pharmacovigilance responsible person representation
• Scientific qualified person representation
• Contact point for all your medical information enquiries and responses
• Contact point for adverse event reporting, processing and regulatory reporting
• Medical review and signatory for medical information, scientific and promotional materials





Clinical Trials Support Service


• Safety input in design of clinical studies
• Medical review of serious adverse events
• Narrative writing
• Writing clinical study reports





Training Services


• One to one training
• Small group training
• Introductory pharmacovigilance for non-scientists
• Overview drug safety risk management for senior management
• In-house training
• Risk management training
• SOP training





Recruitment Services


If you are looking for a job in pharmacovigilance, drug safety or risk management, contact us and we conduct tailored job search on your behalf. Our associates have extensive network of contacts in CROs, small, medium and big pharmaceutical and biotech companies. We can put you in touch with good companies.

If you want to move from another function or discipline to drug safety, we can provide you with practical training to get you up to speed fairly quickly and help you search for suitable positions.





Inspection Readiness Services


• Inspection readiness training
• Preparation of summary of pharmacovigilance systems
• Internal audits
• Mock interviews
• Qualified person for pharmacovigilance representation