Whether we embrace it or not, the Data and Application economy is upon us. Every business is, in some respects, a digital business, and in the digital realm things change FAST. The term ‘cloud’ as a technology concept has been in use since at least 1971, but even as recently as 2009 companies like IBM […]
Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing for these risks, turning risk management into a sustainable competitive advantage. For drug manufacturers, recent trends have underscored the importance of managing Regulatory risk in order to remain […]
On April 25, Terri Nataline and Fran Zipp participated in a summit focusing on global strategies for Indian pharmaceutical companies, the Annual Global Pharma Regulatory Summit, in Mumbai, India. This summit brings together global regulators who shared their knowledge about complying with international regulatory guidelines for manufacturing and exporting pharmaceuticals. Terri Nataline, Principal Consultant, presented […]
On April 21, President and CEO of Lachman Consultants Fran Zipp gave a presentation at the 6th Annual Generic International Summit (GIS) in Shanghai, China. Her talk, “Data Integrity and Quality Culture” was part of a session on “Consistency Evaluation and Formulation”. She discussed the history of Application Integrity Policy (AIP), recent trends in data […]
Lachman Consultants was the Business Exposition Sponsor at the Generic Pharmaceutical Association Annual Meeting in Orlando, held February 22-24, 2016. If we didn’t see you there, we hope to see you at our booth there next year!
From March 14-15, LCS hosted a booth at the PDA Annual Meeting in San Antonio, Texas. The meeting was attended by over 850 pharmaceutical professionals, representing both industry and regulators. Linda Evans O’Connor, Director, and Michele Sinoway, Senior Manager, met with many potential clients and FDA representatives, and are sure this will be a very […]
On Tuesday, March 15, 2016, our President and CEO Fran Zipp and Senior Associate Terri Nataline presented in a forum entitled “GDUFA II and GMP API Inspection Trends: The Business Impact of Upcoming Regulatory Changes” at DCAT Week. DCAT Week is the premier business development event for companies engaged in pharmaceutical development and manufacturing and […]
When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new […]
I am pleased to announce that effective January 1, 2016, Frances “Fran” Zipp is President & Chief Executive Officer of Lachman Consultants.
The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on.
