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LAUNCHED: BioFabConsulting's Regulatory Resource Library

ARMI | BioFabUSA is in constant pursuit of innovative projects that provide top-notch services to benefit our members. With this goal in mind, ARMI | BioFabUSA is pleased to announce the launch of BioFabConsulting’s Regulatory Resource Library.

The Regulatory Resource Library was a summer internship project completed by Katrina Wells, a Biotechnology major at UNH Manchester, and acts as a unique library for regulatory-related documents. Helpful documents providing direction on the regulatory guidelines and standards related to tissue engineering and regenerative medicine were collected from the world’s leading regulatory authorities to create a one-stop-shop for members with uncertainty on the regulatory process and the steps needed to bring a product from conception to the market. The collected documents discuss requirements related to manufacturing, preclinical testing, clinical trial design, and other pivotal steps throughout the total product lifecycle of medical devices, biologics, drug, and combination products. The documents found in this library can also be used to enhance a member’s experience in a BioFabConsulting meeting by providing additional clarity to regulatory procedures pertinent to the development of their medical product.

This library has been conveniently set up to provide users with categorized information about each regulatory document, and the hundreds of documents that have been amassed within the library can be filtered to make navigation through the resources as user-friendly as possible.

Along with acting as a centralized, easy-to-use source for useful regulatory documents, the Regulatory Resource Library is supplemented with a glossary that provides the definition and description of common abbreviations used within the medical product regulatory world. These descriptions help to further clarify the best regulatory pathway for a new medical product by enabling the understanding of what individual regulatory terms mean, and how various regulatory components can be linked together to form a unique regulatory pathway based on certain product characteristics.

The Regulatory Resource Library will be frequently updated with new guidance documents to ensure our members have apt access to the most up-to-date guidance on regulation. Members who are unclear on regulatory procedures can turn to BioFabConsulting’s Regulatory Resource Library to find the right document to guide their product from conception to the market. A meeting with the field experts heading BioFabConsulting, Dr. Richard McFarland and Dr. Becky Robinson-Zeigler, can be scheduled to help guide a product through the regulatory process.

The Regulatory Resource Library is a unique tool exclusive to ARMI | BioFabUSA members. Become a member of ARMI | BioFabUSA now to gain access to this valuable tool!