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We provide a full range of writing services for regulatory submissions and medico-marketing materials across broad
therapeutic areas for all the phases of drug development on a fee-for-service basis. We ensure timely delivery of accurate, consistent and
compliant documents to our sponsors and partners in a cost effective, sustainable, and flexible manner. Our medical writers are highly
qualified communication specialists with backgrounds in medical, pharmaceutical and life sciences. They have a combination of expertise in
clinical research, regulatory guidelines, scientific communications, and technical skills in document development and management. Document
management is done under stringent security measures to maintain data confidentiality. All documents conform to ICH-E3 guidelines and are
finalized after undergoing stringent peer review and quality control checks, followed by management reviews.
Service Offerings:
- Investigator Brochures
- Protocol Development
- Protocol Writing and Protocol Amendments
- IND Annual Reports
- Full and Abbreviated Clinical Study Reports
- Patient Narratives
- Clinical Trial Registry Synopses
- Manuscripts, Abstracts and Posters
- Slide Decks
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