Our consultants have experience in all phases of development from pre-authorisation through post-approval, and can assist you with clinical development plans, concepts in trial design, risk management and marketing plans and set-up of your safety departments.

Our complete menu of services can address your needs in the pharmacovigilance arena including the following areas:

• GAP analysis and set-up or reorganisation  of your drug safety department and pharmacovigilance system
• Assistance with regulatory authority consultation meetings
• Eudravigilance registration (e.g. named person, responsible person, clinical trial application (CTA) or registration for MAH)
• Qualified Person responsible for pharmacovigilance (QPPV) in the EEA
• Risk management and crisis management systems and planning
• Pharmacovigilance audits
• EMEA/Agencies: access to routine consultation meetings, ad hoc agency requests
• Establishment of MAH’s labeling committee
• Safety and pregnancy registries
• Management of joint ventures (one substance and multiple MAHs) and of multiple co-players of one MAH (e.g. multiple pharmacovigilance agreements)