Q2 2020

GHP / Q2 2020 13 , Remarkable Regulation Support Secures Success In the Biotechnology Awards 2020, Global Health and Pharma sought to identify the best that the industry had to offer. Today, we highlight the work of TAF Group LLC, a consulting company focused on the biopharma industry who was named the Best Aseptic Process Training & Regulatory Support Consultancy – USA. Join us as we take a closer look at exactly what makes this consulting company the crème of the crop. Offering a broad range of services from manufacturing and process design, to quality assurance and regulatory support, TAF Group LLC continues to be one of the finest companies with extensive experience in aseptic processes and sterility assurance programs. Whatever the client requires, the consulting company aims to provide nothing but the best, and can provide internal or external audit support to ensure a client’s company is in total compliance with current regulatory requirements. From small-scale, localized start-ups, to global pharmaceutical brands, there is no company that TAF Group LLC will not work tirelessly to support. Initially, the original focus of TAF Group LLC was to support companies in the technical transfers for aseptic processes. As the company matured, and based on the experience of the employees, it quickly evolved into supporting a broader range of biopharma industry needs, spanning across all facets of an organization, including quality control, manufacturing, and validation amongst others. Working alongside companies in different regions often requires a broad range of knowledge, and TAF Group LLC understands the complex current regulatory requirements for many different regions and target markets. Keeping its finger on the pulse, it also frequently reviews regulatory changes, company 483s, warning letters, regulatory publications, the various networks, and attends various seminars and industry conferences in order to stay ahead. TAF Group LLC is still a relatively small company, where clients interact directly with the company owner and principle consultant in order to determine the scope and deliverables of a project. Depending Feb20171 on those factors, the owner may perform the work themselves, or will have direct oversight on anyone supporting the project. The mission of TAF Group LLC is not to dilute the skillsets of its employees by taking on hundreds of projects at a time, but to have more of a high quality and direct focus on a handful of clients so as to build those long term relationships. With more than twenty five years of experience in the industry alongside some of the biopharma companies in the world, TAF Group LLC brings a very large network of consultants and contractors spanning every aspect of a biopharma company to the table. The owner at TAF Group LLC performs all interviews personally and does not use contract services for personnel selection. That way, the client can rest assured that everyone they work with as part of the TAF Group LLC service has been handpicked by an industry veteran. Once implemented, every employee and client alike benefits from a culture of transparency. For example, if it is felt that certain objectives and timelines are not realistic, then a discussion with everybody involved will take place to ascertain how TAF Group LLC can still provide high quality deliverables whilst meeting client needs. As is the case across most of the world, this is an unprecedented time for the pharma sector due to the very recent global pandemic of Covid-19 and the pursuit of a vaccine, the biosimilar market, and new technologies for treating disease. Whilst the Covid-19 is devastating virus, it has propelled hundreds of companies to research and developed anti-viral vaccines which are certain to be required by billions of people all over the world. This necessity breeds opportunity at every level of the industry, and will enable companies to provide valuable jobs to people at all levels. Despite the great opportunity, there is also great risk and challenge to the work that must be done. Companies run the risk of not fully understanding the requirements to bring a product to market from quality and manufacturing perspective. This is where TAF Group LLC can bridge those gaps, either through the auditing of a company, or bringing a support team onboard to collaborate with the client in ensuring the success of getting a product to patients. The future for TAF Group LLC is now growing the business and continuing to support clients with their regulatory and compliance needs, wherever they may be in the world. As new technologies and treatments are continually emerging, so too will TAF Group LLC continue to innovate and develop to support clients in new ways, against new uncertainties, and to develop new products. Company: TAF Group LLC Contact: Paul Andrea Website: www.tafgroup.us

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