For any new drug to be approved for sales and marketing, it is mandatory that it is approved by FDA through a New Drug Application (NDA) submission. The data gathered during the pre-clinical studies and clinical trials of an Investigational New Drug (IND) form part of NDA. The detailed documentation should capture supporting data and evidence about various aspects of drug as its ingredients, results of studies on animals, its pharmacokinetics, outcome of clinical trials and other data as laid down in regulatory requirements. It should also incorporate details on its manufacturing process and packaging.
At VIMTA, we help all our customers in regulatory filings, including submissions for Investigational New Drug (IND) and New Drug Application (NDA). The data is meticulously tabulated and reviewed in accordance with the defined guidelines and regulatory compliances to ensure that each and every particular is effectively captured and supported by relevant data.