Surpass your Quality compliance and Regulatory goals!
Write, review, QC, hyperlink and compile all modules of IND, ANDA, NDA such as CMC section, module 2 clinical and non-clinical summaries etc. and execute the submission to FDA in eCTD format. The content of the modules would be reusable across products, countries and subsequent submissions without major re-work.
Submit subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was not made in eCTD format.
Write and compile pre-IND submission package for FDA review.
Write, review and compile 510(k) and pre-market application (PMA) for medical devices or drug-device combination products.
Drug product registration and establishment registration with FDA.
Serve as a liaison with regulatory agencies pertaining to assigned products/ teams.
Write/ review/ compile annual product report and other technical documentation.
Pharmacovigilance services
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