Description
Appletree AG Appletree CI Group is an expert niche CRO and global regulatory affairs service provider with track-records in ophthalmology, medical devices, dermatology and pediatrics. We are locally present in 11 European countries and have about 50 permanent staff. By having an in-depth understanding of local cultures and customs, as well as experience with national regulations we are able to facilitate your clinical development and regulatory projects.
Expertise and Experience:
Clinical research: focus on ophthalmology, medical device investigations, dermatology and pediatric studies, phases I - IV, pre- and post-marketing studies
Medical writing, consulting, pharmacovigilance, QA/ QC
Data Management and Biostatistics
Regulatory affairs on a global scale
Drug Regulatory Affairs:
Clinical trial authorizations in Europe
Marketing authorization applications (MAA)
Life cycle management, variations management
Medicines and medical devices