Our scope of activities

Regulatory Strategies and Liaison with Competent Authorities
Including but not limited to: MRP/DCP strategies, organization of EU-scientific advice meetings

Clinical Development Consulting
Phase I-IV protocol development for various ongoing trials in dementia, T2DM, gynecology, osteoporosis

Product Lifecycle Management
Upgrade of dossiers, handling variations - services provided for companies from any facet of the pharmaceutical industry

Pharmacovigilance
PSURs, DDPV, Risk management and Risk minimization plans, SOPs

Outcome research and Cost-utility analysis

Labeling and Readability Services
>70 User Tests of Package Leaflet already approved or submitted

Due Diligence
Advising dossier transfer/licensing in a number of successful deals