ACTON, MA, April 13, 2010 — BioProcess Technology Consultants announces the publication of an updated series of guides to the US and international regulations governing the research, development, and manufacture of biotechnology and pharmaceutical products, commonly referred to as the “GxP Regulations.”
The three guides, Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice, present an up-to-the-minute analysis of all the regulations covered, summarizing the latest GxP regulations and guidances issued by regulatory authorities in the US, Canada, the European Union, and Japan.
The series, now in its fourth edition, is intended to aid companies seeking information and practical advice on efficiently establishing full GxP regulatory compliance. Guides provide simple and concise interpretation of regulations and outline effective solutions for their implementation in the nonclinical, manufacturing, and clinical environments. They include templates for SOPs, and other forms that can be copied and used directly. “In addition to being stand-alone references to the complex GxP regulations, these guides can also serve as manuals for in-house training courses,” said Patricia Seymour, BioProcess Technology Consultants Senior Consultant and co-author of the guides. “Several top-tier companies have used previous editions for training, and we expect others to do the same with these updated versions,” added Ms. Seymour.
“These guides provide clear recommendations for full GxP compliance with the global regulatory requirements and will be a valuable tool whether you are an academic, start-up company or well-establish commercial entity,” commented BioProcess Technology Consultants president and founder Howard L. Levine, Ph.D.
Each report is available through BioProcess Technology Consultants in hard copy for $499 and purchasers buying all three guides will receive a discount on the overall purchase price. For detailed information and to order, visit http://www.bioprocessconsultants.com/regulatorycomplianceguides.php.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants is a worldwide leader in biologics CMC consulting, providing a full range of technical, regulatory, and strategic assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® It helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. It regularly assists clients in developing GxP compliant systems and also provides GxP auditing services. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.
