Headquartered in India, I 3 Consulting is a regulatory specialist with global repute and recognition. It is offering superior yet affordably priced Drug Master File services.
Bangalore, India -- (SBWIRE) -- 02/09/2016 -- When business establishments ranging from startups to fortune 500 companies feel the need of regulatory consultation, they more often end up with I 3 Consulting, an India based regulatory specialist with global footing. With a team of professionals falling from diverse backgrounds including medical device, pharmaceuticals, cosmetics, food and nutraceutical regulatory practice, the regulatory specialist strives to live up to their expectations at all times. Currently, I 3 Consulting is extending diligent services to enterprises based in America, Europe, Middle East and Asia-Pacific.
With the intent to offer some insight into the Drug Master File, one of the executives at I 3 Consulting recently stated, "US FDA requires all manufacturers in health and well being segment to submit comprehensive information about their facilities along with manufacturing, processing, storage and packaging processes. Filing for DMF is essential for two or more companies that collaborate for developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details."
The US DMF contains factual and complete information on all aspect of the drug including, but not limited to, chemistry, manufacture, stability, purity, impurity profile, packaging and the cGMP status of any human drug product. Considering the diverse requirements, filing a DMF is a tedious task, which calls for some professional help. I 3 Consulting has the experience of handling Drug Master File requirements of major players in the niche segment, which adds to its credibility.
Shedding some light on the Drug Master File services on offer, the executive further stated, "Discarding the 'one size fits all' theory, we focus on delivering services that corresponds to the diverse requirements of the client. Our FDA DMF Submission Scope is as wide as it can be. The client needs to furnish essential documents for creating DMF and we will go about the task at the right earnest. Our experts will identify all records, reports, chemistry needs to furnish in the submission file and edit and organize DMF information as per FDA required format."
On completion of the DMF, I 3 Consulting will send it to the client for review and acceptance. Additionally, the regulatory specialist is always open to rectify any loopholes, which however is a rarity, in the file. Facilitating a seamless experience, I 3 Consulting is willing to communicate with FDA on behalf of the client, provided the client issues letter of authorization to FDA. Catering to the ultimate in customer delight, I 3 Consulting offers comprehensive annual maintenance for the submitted Drug Master File. Aside from this, I 3 Consulting offers information on 21 CFR 820 and information on FDA drug establishment registration.
About I 3 Consulting
With the base of operations in India and branch offices in the US, I 3 C Global is a regulatory specialist with a tremendous record of accomplishments. It has a seasoned team of experts specializing in medical device, pharmaceuticals, cosmetics, food and nutraceutical regulatory practice, which is catering to businesses in domestic as well as offshore locations. Of late, I 3 Consulting has emerged as one stop solution for enterprises looking for Medical Device CE Marking Service and U.S. FDA Drug Master Files.