Our expert medical writing team supports the development of the following types of documents:
Clinical Documents
- Protocols and Protocol Amendments
- Informed Consent Forms
- Clinical Study Reports
- Clinical Pharmacology Reports
- Clinical Evaluation Reports
- Study Procedure Manuals
- Patient Safety Narratives
- Investigator Brochures
- Annual Reports
- Periodic Safety Update Reports
- Development Safety Update Reports
- Drug Safety Monitoring Committee Charters
Regulatory Documents
- Investigational New Drug Applications (INDs)
- Orphan Drug Designation Applications
- Recombinant DNA Advisory Committee Applications
- Pediatric Investigation Plans
- Marketing Applications
- Clinical Trial Authorisation (CTA)
- New Drug Application (NDA)
- Marketing Authorisation Application (MAA)
- Biologics License Application (BLA)
- Orphan Medicinal Product Application
- Premarket Notification 510(k)
- Premarket Approval (PMA)
- Clinical and Nonclinical Summaries (Module 2)
- Integrated Summaries of Efficacy and Safety (Module 5)
- Regulatory Responses
- Regulatory Briefing Documents
Scientific Communications
- Manuscripts
- Abstracts
- Conference slide kits
- Posters
- White papers
Working Together
Let our team support your clinical, regulatory and scientific writing needs. Together we can make a difference in facilitating the development of your therapy.