I 3 Consulting Offering Expert Regulatory Assistance in the US FDA DMF Filing

I 3 Consulting, a regulatory consulting firm providing service to EU and US FDA Compliance. Our services fits to Fortune 500 and individually owned small companies to get quality information and services regarding US FDA Drug Master files and related services.

Committed to provide the best possible regulatory guidance and annual support to medical device, drugs, API, cosmetics, food, and nutraceutical manufacturers, I 3 Consulting is doing commendably great in its niche market segment. From its offices in Bangalore, India, and Chicago, USA, the regulatory specialist firm extends its expertise to clients in America, Europe, Middle East and Asia-Pacific. As of now, over 3000 plus healthcare product manufacturers across the world rely on I 3 Consulting?s expertise to get quality information and the best regulatory services regarding FDA Drug Master Files.

Speaking about regulatory assistance in DMF filing on offer, a senior firm executive at I 3 Consulting commented, ?A drug product is an intellectual property of a manufacturing partner and hence, it makes perfect sense for him to protect it from other partners. However, when doing it, the partner in question is always bound to comply with certain regulatory requirements that may govern the manufacturing, processing, packaging and storing processes. We, at I 3 Consulting, take care of our clients? concerns pertaining to documentation, technical consultancy, US agent service, annual DMF maintenance, and DMF submission as well.?

I 3 Consulting has a dedicated team of 16 professionals who specialize in different areas of expertise. While offering DMF regulatory consultancy services to clients. I 3 Consulting provides expert assistance in preparing necessary documents and identifying reports, records, and chemistry. Furthermore, the professionals submit DMF to FDA in both electronic and paper form, aside from establishing a viable communication with FDA so that client don?t need to worry about this aspect of the DMF filing process. Annual DMF maintenance services on offer include responding to FDA concerns, submitting letter of authorization, and assisting in DMF Closure request submission.

The senior firm executive stated further, ?At I 3 Consulting, we are committed to improve our customers? sales within their countries and across the world. For doing so, we penetrate high entry barrier US market by utilizing our expertise and exploring all possible channels. Thus, over the years, we have enabled our clients to have a competitive edge over their peers so that they could reach out to more customers across the globe.?

I 3 Consulting further organizes and edits DMF information in a way that it conforms to FDA?s required format. Thus, companies looking forward to get regulatory assistance in filing of U.S. FDA Drug Master Files can rely on the expertise of I 3 Consulting.

Based in Bangalore, India, and Chicago, USA, I 3 Consulting is a regulatory specialist firm that has years of experience in providing quality services to medical device manufacturers, pharmaceuticals, cosmetics, food and nutraceutical companies. The list of I 3 Consulting?s clients include several Fortune 500 and individually owned small companies, which is sure to get new entries in the years to come. As of now, the company?s customer base includes several clients from America, Europe, Middle East and Asia-Pacific. Accordingly, over the years, I 3 Consulting has been quite successful in maintaining its position of being the best CE Marking Certification Consultants that specialize in a slew of regulatory practices.

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