Our team of highly capable subject matter experts can help you to produce clear, suitable regulatory documents, detailing all aspects of the drug development process and CMC. Our experts have experience writing clinical study reports, NDA’s, ISS/ISE’s, and IND applications and have the ability to do so in eCTD format. Synowledge provides appropriate subject matter domain-based process expertise to enable all life sciences organizations to fully satisfy their regulatory obligations and responsibilities.
Nonclinical and clinical overview writing
CTD Summary Writing
Literature review for quality/BE studies / Clinical /Non Clinical Overviews
Preparation of Summary of Product Characteristic (SmPC), Pack Insert, and Product rationale
Proficiency in creating detailed NDA, ANDA, ISS, ISE, and IND applications (Module 1 ,2,3,4 and 5 )