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Regulatory writing

ClinScript offers the scientific expertise and industry experience required to provide the full range of writing and coordination services for the documentation demanded by your clinical development plan. Our services include:

• Cohesive and consistent communication of key messages throughout your product lifecycle.
• Application of industry best-practices and standards in document preparation.
• Efficient processes to meet tight deadlines.
• Continuous and thorough quality control.
• Management of your entire documentation cycle

• Electronic Common Technical Document (eCTD)
• Investigational Medicinal Product Dossier (IMPD)
• Investigational new drug (IND) applications
• Clinical Study Reports (phases I to IV), compliant with ICH E3 standards
• Clinical Protocols and Amendments
• Investigator's Brochure and annual updates
• Patient narratives
• OTC switch reports
• FDA briefing documents
• Proposed labeling / annotated package inserts
• Postmarketing experience reports
• Patient information and informed consent forms
• Scientific and Protocol Advice
• Expert Reports