Medical/Technical Writing
MORIAH's medical consulting and writing services facilitate and
support the successful completion of your studies and regulatory
submissions. Our staff draw on their in-depth regulatory experience
to assure that your study reports meet the highest standards and
fully comply with all regulations. Our writers provide comprehensive
document development capabilities to ensure that your data are
presented accurately, factually and in the appropriate format
for regulatory authorities. MORIAH's worldwide consulting and
writing services include consultation, strategic planning and
medical/technical writing.
Medical Consultation Services
- Regulatory Strategic Planning
- Assessment of pharm/tox, biopharmaceutic and clinical/scientific
data
- Development of clinical operating plans
- Study Design
- Review of Documents
- Representation at Regulatory Agency Meetings
Medical/Technical Writing Services
- Standard Operating Procedures (SOP)
- Investigator Brochures
- Protocols
- Informed Consent Forms
- Study Manuals
- Quality Manuals and CAPA Processes
- Integrated Study Reports
- Expert Summaries for international regulatory submissions
- Abstracts and journal articles
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