Services
At Accovion, no project is too large or too small. Examples of documents we can prepare are:
- Clinical study protocols and amendments
- Subject information leaflets and informed consent documents
- Investigator brochures
- Investigational medicinal product dossiers
- Pediatric investigation plans
- Clinical study reports
- Patient safety narratives
- Clinical summaries and overviews for worldwide regulatory submissions (MAA, NDA, BLA in CTD and eCTD format)
- Responses to questions from regulatory authorities
- Investigational New Drug applications
- Briefing documents for regulatory agencies
- Clinical publication manuscripts
- Standard operating procedures
- Manuals and templates for document standards
Whatever the type and size of the documents you need, we’ll provide consistent text and data presentation that integrates seamlessly into current and future documentation, taking into consideration guidelines, style guides, templates and SOPs to ensure high-quality documents compliant with regulatory and client needs.
We recognize that preparing complex documentation for your product and meeting regulatory agency timelines can be a daunting task. Accovion has the resources and expertise to complete your documentation, while keeping you informed of the progress every step of the way. Your assigned team will work closely with you to ensure consistent data interpretation and presentation across all documentation.
Damien Lynch, PhD
Director, Medical Writing and Electronic Publishing
+49 6196 7709-301
