Pharmacyte Biotech Inc (OTCMKTS:PMCB) currently working on its Investigational New Drug application and has sought the expertise of cGMP Validation to ensure that they submit a flawless masterpiece to the U.S Food and Drug Administration (FDA) for vetting.
The IND is for its proprietary Cell-in-a-Box®, a futuristic technology for live-cell encapsulation targeted for Cancer and Diabetes patients. The IND submission to the FDA is important for the company as it is through the same that the licensing board will determine whether to approve or decline the drug’s use.
With the guiding of cGMP Validation, the company will be in a better position to submit a a sound application that will sure pass the vetting process. cGMP Validation has been in business for over two decades now and is conversant with the process. The company has a host of satisfied clientele across several continents. The company delights a skilled management with intense pharmaceutical experience led by its President and Chief Executive Officer, Jesse Gillikin.
cGMP Validation impressive portfolio
cGMP Validation serves a variety of clients ranging from the pharmaceutical, biotechnology and medical diagnostic spheres among many others. Its role is to ensure that companies meet FDA’s cGMP requirements while submitting their INDs. cGMP Validation steps in to validate companies’ manufacturing equipment, ensure that the manufacturing process is compliant, confirm that the company adheres to cleaning standards and computer validation. The vast experience the company has garnered over the years puts it in a position to draft and even enforce validation doctrines.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner speaking about the pending processes before the innovative drug is available to patients said that, “Our checklist of items to be completed has been whittled down to just a few remaining items, and cGMP Validation provides us with the confidence moving forward to get across the finish line.”
Due to the urgency of the process, the company has since suspended its over scheduled shareholder meeting to Q1 2019 in order to complete the IND preparation and submission.