Medspero provide effective Regulatory technical writing Guidance requires in many areas during the regulatory process.
We provide expert advice and guidance in preparing the clinical and nonclinical modules of your dossier (M2.4, M2.5, M2.6, M2.7, M4, and M5), and Environmental risk assessments (M1.6.1 and 1.6.2).
We provide extensive guidance regarding the preparation of promotional material, Indications, Claims etc.
Clarity and accuracy are essential for communicating effectively with your audience. Clear, precise, unambiguous, and accurate writing will also aid in navigating the regulatory review process smoothly. Here are some examples of technical reports that we have created:
- Non-clinical (M 2.4, 2.6) and clinical (M 2.5, 2.7) components of the CTD dossier for Marketing Authorization Applications (EU), NDAs/BLAs to the FDA in accordance with NtA Vol 9B.
- Integrated Safety and Effectiveness Summaries (ISS/ISE)
- Environmental assessments (EU/US) and environmental risk assessments
- ERA bibliographic preparation.
- Data organisation for generic products' sales
- Briefing documents for meetings of regulatory authorities / scientific advice
- Instructions for Use
- Technical Files
- Design Dossiers
- Annual Reports
- Substantial Equivalence Assessments