Build robust Quality management systems (QMS) tailored to any regulatory compliance strategy with fast turnaround time.
Analyze procedures based on client and product-specific requirements and develop/ review customized standard operating procedures (SOPs).
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• 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. Pharmacovigilance services
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