Medical and scientific writing

In pharmaceutical drug development value is primarily generated by documentation. The saying is: “an experiment which is not documented is no experiment”.

We review your data and produce for you high-quality documents that meet your exact requirements and those of the regulatory authorities. Our services include:

• Quality documentation
• Non-clinical reports
• Investigator brochures and updates
• Briefing documents for Scientific Advice
• Study protocols
• Clinical study reports (Phases I to IV)
• CTD preclinical and clinical summaries and overviews
• Clinical trial registry and database summaries
• Clinical trial authorisations/investigational new drug applications
• Summary of Product Characteristics
• Patient Information Leaflets

• Regulatory Strategy
• Regulatory Procedures
• Advanced Therapies
• Orphan Drug Development
• Paediatric Development
• Medical Devices
• Borderline Products
• Authority Meetings
• Electronic Submissions
• Market Access & Value Dossier
• Small & Medium Enterprises
• Medical Writing
• Project Management
• Due Diligence

• Business Development