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Since 1978, Lachman Consultants’ multidisciplinary team of highly experienced FDA and industry experts has offered compliance, regulatory affairs, and technical services to clients around the world.
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Our blogs feature and report on the latest news and trends in the industry.
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Latest Blogs

Can We Call It the Affirmation of a “Beautiful Friendship”?

FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.  The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was initiated in 2015.

Understanding the Mutual Recognition Agreement (MRA)

It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now.  As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and to harmonize standards within the industry.  

New FDA Guidance Released on Live Case Presentations for IDE Clinical Trials

We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events.  In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached.  We can stream tv shows, live news reporting and sports events in real time.  

We Were Close – June Was A Bit Of A Bust

OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing.  We missed the approval actions by one.  OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of 62 approval actions for June 2019. 

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Latest News

Frances Zipp of Lachman Consultants to be Featured Speaker at Annual Medicines for Europe Conference

(Westbury, NY – May 2019) Lachman Consultant Services, Inc. (“Lachman Consultants”), a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide, will be participating as a Conference Sponsor at the 25th annual Medicines for Europe and IGBA Conference. Entitled “Committing to Global Health – Balancing Access and Sustainability,” this year’s event is focused on generic,

Accomplished Global Pharma Executive Mary Oates Joins Lachman Consultants, Inc. as VP of Compliance Services

(Westbury, NY – April 2, 2019) Fran Zipp, President and CEO of Lachman Consultants, Inc. a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that comprises Lachman’s Compliance Practice Group,