Drug regulatory affairs
- Strategic consultancy (for NCEs, Biotech, Veterinary, homeopathics, Medical Devices) for national, EU centralised and MR procedures
- Development Planning: Pre- and Clinical Phases I – III, Regulatory affairs
- Marketing Authorisation Applications and monitoring (EU national, MRP, CP, DCP, US, Turkey, near East)
- CTD and eCTD services
- User testing
- expert opinions / non- and clinical summaries etc
- Authoring SPC’s / PILs and label texts according to “Notice to Applicants”
- Database search for references
- All Regulatory work for clinical trials in EU
- Reg. affairs . Office for DE and AT, EU in general
- Post marketing: variations, renewals, OTC-switch
- Pharmacovigilance: PSURs, SUSARs, QP for Pharmacovigilance function, literature survey
- Pricing & reimbursement in CEEC
- Due diligence services for mergers, acquisition or product transfer, evaluation of dossiers
