Clinical Medical Writing
QABASA has vast and extensive experience in authoring the clinical components of marketing applications, including New Drug Applications (NDAs) and Biologics License Applications (BLAs) in the US and Marketing Authorization Applications (MAAs) in Europe.
Our area of expertise includes Veterinary Medicines, Over-the-Counter Medicines, Prescription Drugs, Biologics and Medical Devices.
Our team of expert writers can help you with:
- Phase I-IV protocols
- Phase I-IV integrated clinical statistical reports (ICSR)
- Standard Operating Procedure (SOP) writing
- Global clinical trial applications
- Drug, device and biologics marketing applications
- Regulatory Submissions
- (eCTD, IND, NDA, INAD, NADA, BLA, CTA)
- Expert Reports
- Product Dossiers
- Safety Narratives
- Labeling