GloBus Consulting Services, Inc., a Philadelphia, USA based corporation that provides a variety of services to the pharmaceutical, biotech and API manufacturing industries around the world. "GloBus" stands for Global Business as our goal is to provide strategic business development to our clients with no borders in sight and using "out of the box" approach.
GloBus`s strategic business development services involve analysis of the company`s capabilities and assets to amplify the opportunities in the areas where the company has a leading edge or define niche markets where the company can succeed due to its unique expertise. As soon as these opportunities are identified, GloBus can provide marketing or technology brokerage services in developing strategic alliance networks, entering new target markets and aligning and executing product or technology in-licensing or out- licensing activities.
An important prerequisite for doing business in healthcare industry in the global marketplace for any company around the world is being GMP compliant, so it is no surprise that GMP Compliance services is an important part of our business and go hand in hand with our Strategic Business Development services.
Our specialists with an extensive business development and hands-on GMP compliance experience have had provided these services to various companies in the North and South America, Europe and Asia Established in 2002 by industry professionals, GloBus was also involved in several GMP, market research studies and M&A projects in the US, EU, India, China, Central Europe and Russia.
GMP services were provided to many companies involved in manufacturing of Active Pharmaceutical and Biopharmaceutical Ingredients (API) (the entire range of services required to set-up and maintain the essential quality systems to comply with FDA regulations). Remedial actions to overcome FDA Warning letters, preparing the companies for FDA and other regulatory audits, preparing responses to the audits. Market development involved companies manufacturing both API`s and biopharmaceuticals (recombinant human proteins, peptides) as well as advanced and penultimate intermediates and custom chemicals. GloBus was also involved in technology licensing (biotechnology, chemistry) and technology transfer, mainly from Russia to India, laboratory processesí development with further scale-up and commercialization (development of the lab scale processes in Russia - technology transfer and scale-up in India for market in U.S.A.). GloBus has provided market research and marketing services in the area of biotechnology and diagnostics (products and technologies) and utilization of fermentation capacities, as well as R&D services to companies in Mexico, India and Russia.
In 2004 GloBus was contracted by International Science & Technology Center (ISTC), Moscow, Russia and Bio Industry Initiatives of the US Department of State (BII) to conduct a GMP assessment (according to US FDA, EU and local regulatory requirements), market research study and conceptual design of the facility in Russia, involved in the R&D activities and pilot scale manufacturing of biopharmaceuticals, as a part of the non-proliferation program for advances technologies in the Independent States of Former Soviet Union.
GloBus has set up and orchestrated the $12.5mln acquisition of API manufacturing company in US, including business and regulatory/compliance due diligence. GloBus is currently involved in developing and implementing a business plan for this facility, to include technology transfers, outsourcing and marketing of products and services.